driven by clinical

EVIDENCE

Jobevne™ has achieved all the benchmarks for biosimilarity in efficacy and safety to the reference bevacizumab.1,2
Totality of evidence for JOBEVNE is based on similarity in analytical and clinical data, along with extrapolation of indications to Avastin®.1,2

EFFICACY

This Phase 3 study compared the efficacy and safety of JOBEVNE with Avastin, as first-line treatment for 671 patients with stage IV non-squamous non-small-cell lung cancer.

JOBEVNE study
JOBEVNE study

Study Endpoints1

    • The primary efficacy endpoint was the overall response rate (ORR) at Week 18
    • The key secondary efficacy endpoints were progression-free survival (PFS) and overall survival (OS)
    • Immunogenicity testing was performed to detect anti-drug antibodies (ADAs) and neutralizing antibodies against
JOBEVNE and Avastin

Baseline Characteristics1

    • Demographics and baseline disease characteristics were well balanced between treatment groups with respect to age,† race, height, and ECOG status

*JOBEVNE was dosed at 15 mg/kg infusion.
†Eligible patients were adults ≥18 years of age.

ECOG=Eastern Cooperative Oncology Group; EOT=end of treatment; R=randomized.

  • Primary endpoint: ORR was comparable between treatment groups at Week 18
  • ORR ratio (0.96; 90% CI: 0.83, 1.12) and ORR difference (-1.6; 95% CI: -9.0, 5.9) were within their predefined equivalence margins*
JOBEVNE vs Avastin ORR at Week 18

*ORR ratio 90% CI equivalence margin was defined as 0.73 to 1.36, and ORR difference 95% CI equivalence margin was defined as -12.5 to 12.5.

CI=confidence interval; IR=independent review; ORR=overall response rate.

There were no statistically significant differences in PFS at Week 42 between treatment groups.

JOBEVNE vs Avastin PFS at week 42

*No statistically significant difference between treatment arms at 42 weeks; the log-rank test showed a P-value of 0.0906 (IR) between the
 treatment arms.

†The median OS was not reached in the ITT population at Week 42. According to the log-rank test, the difference between the survival curves
 for both treatment groups was not statistically significant (P=0.1185).

CI=confidence interval; IR=independent review; ITT=intent-to-treat; NC=not calculable; OS=overall survival; PFS=progression-free survival.

SAFETY

No clinically significant differences were observed between JOBEVNE and Avastin in the incidence of treatment-emergent adverse events (TEAEs) and severity of immune responses.

Overall Incidence of Treatment-Emergent Adverse Events1

Includes Period 1 and Period 2 through Week 42.

Incidence of TEAE in treatment groups1

JOBEVNE vs Avastin incidence of TEAE in treatment groups
JOBEVNE showed:
  • Similar incidence of treatment-emergent ADAs compared with Avastin
  • Similar incidence of neutralizing antibody post-baseline compared with Avastin

ADA=anti-drug antibody; IMP=investigational medicinal product; TEAE=treatment-emergent adverse event.

REFERENCES

1. Socinski MA, Waller CF, Idris T, et al. Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer. Ther Adv Med Oncol. 2021;13:17588359211045845. 2. US Food and Drug Administration. Biosimilars: review and approval. Last updated December 13, 2022. Accessed June 16, 2025. https://www.fda.gov/drugs/biosimilars/review-and-approval

INDICATION AND Important safety information

INDICATION

Fulphila® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive 
anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use:

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation

IMPORTANT SAFETY INFORMATION 

Do not administer Fulphila to patients with a history of serious allergic reactions, including anaphylaxis, to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Fulphila for ARDS. Discontinue Fulphila in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment. Permanently discontinue Fulphila in patients with serious allergic reactions to any pegfilgrastim or filgrastim products.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue if sickle cell crisis occurs.

Glomerulonephritis has been reported in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Fulphila.

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of CBCs during therapy with Fulphila is recommended.

Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

The G-CSF receptor, through which pegfilgrastim and filgrastim products act, has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology and discontinue Fulphila if aortitis is suspected.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.

The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see Full Prescribing Information.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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IMPORTANT SAFETY INFORMATION

JOBEVNE can cause serious side effects, including:

Gastrointestinal (GI) perforations and fistulae: Serious, and sometimes fatal, gastrointestinal perforation occurred at a higher incidence in patients receiving bevacizumab products compared to patients receiving chemotherapy.  The incidence ranged from 0.3% to 3% across clinical studies, with the highest incidence in patients with a history of prior pelvic radiation. Serious fistulae ranged from < 1% to 1.8% across clinical studies, with the highest incidence in patients with cervical cancer. Avoid JOBEVNE in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. Discontinue in patients who develop gastrointestinal perforation, tracheoesophageal fistula, or any Grade 4 fistula. Discontinue in patients with fistula formation involving any internal organ.

Surgery and Wound Healing Complications: The incidence of surgery and wound healing complications, including serious and fatal complications, was increased in patients receiving bevacizumab products. In patients who experience wound healing complications during treatment, withhold JOBEVNE until adequate wound healing. Do not use JOBEVNE for at least 28 days following major surgery, to allow time for the wound to heal. Discontinue JOBEVNE in patients who develop necrotizing fasciitis.

Hemorrhage: Severe or fatal hemorrhage including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving bevacizumab products vs chemotherapy alone. Discontinue JOBEVNE in patients who develop a Grades 3-4 hemorrhage.

Arterial Thromboembolic Events: Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, and angina, occurred at a higher incidence in patients receiving bevacizumab vs chemotherapy. Discontinue JOBEVNE in patients who develop severe ATE. The safety of reinitiating bevacizumab products after an ATE is resolved is not known.

Venous Thromboembolic Events: An increased risk of venous thromboembolic events (VTE) was observed across clinical studies. Discontinue JOBEVNE in patients with a Grade 4 VTE, including pulmonary embolism.

Hypertension: Severe hypertension occurred at a higher incidence in patients receiving bevacizumab products as compared to chemotherapy alone. Monitor blood pressure every two to three weeks during treatment with JOBEVNE. Treat with appropriate anti-hypertensive therapy and monitor blood pressure regularly. Discontinue in patients who develop hypertensive crisis or hypertensive encephalopathy.

Posterior Reversible Encephalopathy Syndrome (PRES): PRES was reported in < 0.5% of patients across clinical studies. Discontinue JOBEVNE in patients who develop PRES.

Renal Injury and Proteinuria: The incidence and severity of proteinuria was higher in patients receiving bevacizumab as compared to patients receiving chemotherapy. Nephrotic syndrome occurred in < 1% of patients receiving bevacizumab products across clinical studies, in some instances with fatal outcome. Discontinue JOBEVNE in patients who develop nephrotic syndrome.

Infusion-related reactions: Infusion-related reactions reported across clinical studies and post marketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, anaphylactoid/anaphylactic reactions, chest pain, headaches, rigors, and diaphoresis. In clinical studies, infusion-related reactions with the first dose of bevacizumab products occurred in < 3% of patients and severe reactions occurred in 0.4% of patients. Decrease the rate of infusion for mild, clinically insignificant infusion-related reactions. Interrupt the infusion in patients with clinically significant infusion-related reactions and consider resuming at a slower rate following resolution. Discontinue JOBEVNE in patients who develop a severe infusion-related reaction and administer appropriate medical therapy.

Embryo-Fetal Toxicity: Bevacizumab products may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JOBEVNE and for 6 months after the last dose.

Ovarian Failure: The incidence of ovarian failure was 34% vs 2% in premenopausal women receiving bevacizumab with chemotherapy vs chemotherapy alone for adjuvant treatment of a solid tumor. Inform females of reproductive potential of the risk of ovarian failure prior to initiating JOBEVNE.

Congestive Heart Failure (CHF): JOBEVNE is not indicated for use with anthracycline-based chemotherapy. Discontinue JOBEVNE in patients who develop CHF.

Most common adverse reactions incidence (incidence >10%): epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Across clinical studies, bevacizumab was discontinued in 8% to 22% of patients because of adverse reactions.

Most Common Adverse Reactions by Indication

Metastatic Colorectal Cancer:

  • in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment (Study AVF2107g): Grades 3-4 adverse reactions occurring at higher incidence (≥2%) in patients receiving bevacizumab with IFL (N=392) vs placebo with IFL (N=396) were leukopenia (37% vs 31%), neutropenia (21% vs 14%), diarrhea (34% vs 25%), abdominal pain (8% vs 5%), constipation (4% vs 2%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), asthenia (10% vs 7%), and pain (8% vs 5%).
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen (Study E3200): Selected Grades 3–5 (non-hematologic) and Grades 4–5 (hematologic) occurring at a higher incidence (≥ 2%) in patients (N=521) receiving bevacizumab with FOLFOX4 compared to FOLFOX4 alone were fatigue (19% vs. 13%), diarrhea (18% vs. 13%), sensory neuropathy (17% vs. 9%), nausea (12% vs. 5%), vomiting (11% vs. 4%), dehydration (10% vs. 5%), hypertension (9% vs. 2%), abdominal pain (8% vs. 5%), hemorrhage (5% vs. 1%), other neurological (5% vs. 3%), ileus (4% vs. 1%) and headache (3% vs. 0%).

First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)

  • Study E4599: Grades 3–5 (non-hematologic) and Grade 4–5 (hematologic) adverse reactions in a clinical study occurred at ≥ 2% higher incidence in patients (N=422) receiving bevacizumab with paclitaxel and carboplatin vs. patients receiving chemotherapy alone were neutropenia (27% vs. 17%), fatigue (16% vs. 13%), hypertension (8% vs. 0.7%), infection without neutropenia (7% vs. 3%), venous thromboembolism (5% vs. 3%), febrile neutropenia (5% vs. 2%), pneumonitis/pulmonary infiltrates (5% vs. 3%), infection with Grade 3 or 4 neutropenia (4% vs. 2%), hyponatremia (4% vs. 1%), headache (3% vs. 1%) and proteinuria (3% vs. 0%).

Recurrent Glioblastoma

  • Study EORTC 26101: In patients (N=278) with recurrent GBM following radiotherapy and temozolomide, patients received bevacizumab with lomustine or lomustine alone, 22% of patients discontinued treatment in the bevacizumab with the lomustine arm compared with 10% of patients in the lomustine arm. In patients receiving bevacizumab with lomustine, the adverse reaction profile was similar to that observed in other approved indications.

Metastatic Renal Cell Carcinoma

  • Study BO17705: Grades 3-5 adverse reactions occurring at a >2% higher incidence in bevacizumab with interferon alfa (N=337) compared to placebo with interferon alfa (N=304), were fatigue (13% vs. 8%), asthenia (10% vs. 7%), proteinuria (7% vs. 0%), hypertension (6% vs. 1%; including hypertension and hypertensive crisis), and hemorrhage (3% vs. 0.3%; including epistaxis, small intestinal hemorrhage, aneurysm ruptured, gastric ulcer hemorrhage, gingival bleeding, hemoptysis, hemorrhage intracranial, large intestinal hemorrhage, respiratory tract hemorrhage, and traumatic hematoma).

Persistent, Recurrent, or Metastatic Cervical Cancer

  • Study GOG-0240: Grades 3 or 4 adverse reactions occurred at a higher incidence of ≥ 2% in patients receiving bevacizumab with chemotherapy (N = 218) compared to patients receiving chemotherapy alone (N = 222), were abdominal pain (12% vs. 10%), hypertension (11% vs. 0.5%), thrombosis (8% vs. 3%), diarrhea (6% vs. 3%), anal fistula (4% vs. 0%), proctalgia (3% vs. 0%), urinary tract infection (8% vs. 6%), cellulitis (3% vs. 0.5%), fatigue (14% vs. 10%), hypokalemia (7% vs. 4%), hyponatremia (4% vs. 1%), dehydration (4% vs. 0.5%), neutropenia (8% vs. 4%), lymphopenia (6% vs. 3%), back pain (6% vs. 3%), and pelvic pain (6% vs. 1%).

Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

  • Combination with carboplatin and paclitaxel, followed by Bevacizumab as a single agent, for stage III or IV disease following initial surgical resection (Study BO17705): Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms vs. the control arm were fatigue (CPB15+ -9%, CPB15 -6%, CPP -6%), hypertension (CPB15+ -10%, CPB15 -6%, CPP -2%), thrombocytopenia (CPB15+ -21%, CPB15 -20%, CPP -15%) and leukopenia (CPB15+ -51%, CPB15 -53%, CPP -50%).
  • Combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (Study MO22224): Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving bevacizumab with chemotherapy (N = 179) vs. patients receiving chemotherapy alone (N = 181) were hypertension (6.7% vs. 1.1%) and palmar-plantar erythrodysaesthesia syndrome (4.5% vs. 1.7%).
  • Combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Bevacizumab as a single agent for platinum-sensitive recurrent disease (Study AVF4095g): Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving bevacizumab with chemotherapy (N=247) compared to placebo with chemotherapy (N=233) were thrombocytopenia (40% vs. 34%), nausea (4% vs. 1.3%), fatigue (6% vs. 4%), headache (4% vs. 0.9%), proteinuria (10% vs. 0.4%), dyspnea (4% vs. 1.7%), epistaxis (5% vs. 0.4%), and hypertension (17% vs. 0.9%).
  • Patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have not received more than one previous regimen of chemotherapy (Study GOG-0213): Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving bevacizumab with chemotherapy compared to chemotherapy alone were hypertension (11% vs. 0.6%), fatigue (8% vs. 3%), febrile neutropenia (6% vs. 3%), proteinuria (8% vs. 0%), abdominal pain (6% vs. 0.9%), hyponatremia (4% vs. 0.9%), headache (3% vs. 0.9%), and pain in extremity (3% vs. 0%).

INDICATIONS

Metastatic Colorectal Cancer (mCRC)

  • JOBEVNE combined with intravenous fluorouracil-based chemotherapy for first- or second-line treatment of patients with mCRC.

  • JOBEVNE combined with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the second-line treatment of patients with mCRC who have progressed on a first-line treatment containing bevacizumab.

Limitations of Use: JOBEVNE is not approved for use if surgery was used as the primary treatment in patients with colon cancer which has not spread to other parts of the body.

First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC):

JOBEVNE combined with carboplatin and paclitaxel is approved for first-line treatment in patients with unresectable, locally advanced, recurrent or metastatic NSCLC.

Recurrent Glioblastoma (rGBM):

JOBEVNE is approved to treat rGBM in adults.

Metastatic Renal Cell Carcinoma (mRCC):

JOBEVNE combined with interferon alfa, is approved to treat mRCC.

Persistent, Recurrent or Metastatic Cervical Cancer (CC):

JOBEVNE combined with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat patients with persistent, recurrent, or metastatic cervical cancer.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer:

  • JOBEVNE combined with carboplatin and paclitaxel, followed by JOBEVNE alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection.
  • JOBEVNE combined with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
  • JOBEVNE combined with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by JOBEVNE alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

JOBEVNE can cause serious side effects, including:

Gastrointestinal (GI) perforations and fistulae: Serious, and sometimes fatal, gastrointestinal perforation occurred at a higher incidence in patients receiving bevacizumab products compared to patients receiving chemotherapy.  The incidence ranged from 0.3% to 3% across clinical studies, with the highest incidence in patients with a history of prior pelvic radiation. Serious fistulae ranged from < 1% to 1.8% across clinical studies, with the highest incidence in patients with cervical cancer. Avoid JOBEVNE in patients with ovarian cancer who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. Discontinue in patients who develop gastrointestinal perforation, tracheoesophageal fistula, or any Grade 4 fistula. Discontinue in patients with fistula formation involving any internal organ.

Surgery and Wound Healing Complications: The incidence of surgery and wound healing complications, including serious and fatal complications, was increased in patients receiving bevacizumab products. In patients who experience wound healing complications during treatment, withhold JOBEVNE until adequate wound healing. Do not use JOBEVNE for at least 28 days following major surgery, to allow time for the wound to heal. Discontinue JOBEVNE in patients who develop necrotizing fasciitis.

Hemorrhage: Severe or fatal hemorrhage including hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving bevacizumab products vs chemotherapy alone. Discontinue JOBEVNE in patients who develop a Grades 3-4 hemorrhage.

Arterial Thromboembolic Events: Serious, sometimes fatal, arterial thromboembolic events (ATE) including cerebral infarction, transient ischemic attacks, myocardial infarction, and angina, occurred at a higher incidence in patients receiving bevacizumab vs chemotherapy. Discontinue JOBEVNE in patients who develop severe ATE. The safety of reinitiating bevacizumab products after an ATE is resolved is not known.

Venous Thromboembolic Events: An increased risk of venous thromboembolic events (VTE) was observed across clinical studies. Discontinue JOBEVNE in patients with a Grade 4 VTE, including pulmonary embolism.

Hypertension: Severe hypertension occurred at a higher incidence in patients receiving bevacizumab products as compared to chemotherapy alone. Monitor blood pressure every two to three weeks during treatment with JOBEVNE. Treat with appropriate anti-hypertensive therapy and monitor blood pressure regularly. Discontinue in patients who develop hypertensive crisis or hypertensive encephalopathy.

Posterior Reversible Encephalopathy Syndrome (PRES): PRES was reported in < 0.5% of patients across clinical studies. Discontinue JOBEVNE in patients who develop PRES.

Renal Injury and Proteinuria: The incidence and severity of proteinuria was higher in patients receiving bevacizumab as compared to patients receiving chemotherapy. Nephrotic syndrome occurred in < 1% of patients receiving bevacizumab products across clinical studies, in some instances with fatal outcome. Discontinue JOBEVNE in patients who develop nephrotic syndrome.

Infusion-related reactions: Infusion-related reactions reported across clinical studies and post marketing experience include hypertension, hypertensive crises associated with neurologic signs and symptoms, wheezing, oxygen desaturation, Grade 3 hypersensitivity, anaphylactoid/anaphylactic reactions, chest pain, headaches, rigors, and diaphoresis. In clinical studies, infusion-related reactions with the first dose of bevacizumab products occurred in < 3% of patients and severe reactions occurred in 0.4% of patients. Decrease the rate of infusion for mild, clinically insignificant infusion-related reactions. Interrupt the infusion in patients with clinically significant infusion-related reactions and consider resuming at a slower rate following resolution. Discontinue JOBEVNE in patients who develop a severe infusion-related reaction and administer appropriate medical therapy.

Embryo-Fetal Toxicity: Bevacizumab products may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with JOBEVNE and for 6 months after the last dose.

Ovarian Failure: The incidence of ovarian failure was 34% vs 2% in premenopausal women receiving bevacizumab with chemotherapy vs chemotherapy alone for adjuvant treatment of a solid tumor. Inform females of reproductive potential of the risk of ovarian failure prior to initiating JOBEVNE.

Congestive Heart Failure (CHF): JOBEVNE is not indicated for use with anthracycline-based chemotherapy. Discontinue JOBEVNE in patients who develop CHF.

Most common adverse reactions incidence (incidence >10%): epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis.

Across clinical studies, bevacizumab was discontinued in 8% to 22% of patients because of adverse reactions.

Most Common Adverse Reactions by Indication

Metastatic Colorectal Cancer:

  • in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment (Study AVF2107g): Grades 3-4 adverse reactions occurring at higher incidence (≥2%) in patients receiving bevacizumab with IFL (N=392) vs placebo with IFL (N=396) were leukopenia (37% vs 31%), neutropenia (21% vs 14%), diarrhea (34% vs 25%), abdominal pain (8% vs 5%), constipation (4% vs 2%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), asthenia (10% vs 7%), and pain (8% vs 5%).
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen (Study E3200): Selected Grades 3–5 (non-hematologic) and Grades 4–5 (hematologic) occurring at a higher incidence (≥ 2%) in patients (N=521) receiving bevacizumab with FOLFOX4 compared to FOLFOX4 alone were fatigue (19% vs. 13%), diarrhea (18% vs. 13%), sensory neuropathy (17% vs. 9%), nausea (12% vs. 5%), vomiting (11% vs. 4%), dehydration (10% vs. 5%), hypertension (9% vs. 2%), abdominal pain (8% vs. 5%), hemorrhage (5% vs. 1%), other neurological (5% vs. 3%), ileus (4% vs. 1%) and headache (3% vs. 0%).

First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)

  • Study E4599: Grades 3–5 (non-hematologic) and Grade 4–5 (hematologic) adverse reactions in a clinical study occurred at ≥ 2% higher incidence in patients (N=422) receiving bevacizumab with paclitaxel and carboplatin vs. patients receiving chemotherapy alone were neutropenia (27% vs. 17%), fatigue (16% vs. 13%), hypertension (8% vs. 0.7%), infection without neutropenia (7% vs. 3%), venous thromboembolism (5% vs. 3%), febrile neutropenia (5% vs. 2%), pneumonitis/pulmonary infiltrates (5% vs. 3%), infection with Grade 3 or 4 neutropenia (4% vs. 2%), hyponatremia (4% vs. 1%), headache (3% vs. 1%) and proteinuria (3% vs. 0%).

Recurrent Glioblastoma

  • Study EORTC 26101: In patients (N=278) with recurrent GBM following radiotherapy and temozolomide, patients received bevacizumab with lomustine or lomustine alone, 22% of patients discontinued treatment in the bevacizumab with the lomustine arm compared with 10% of patients in the lomustine arm. In patients receiving bevacizumab with lomustine, the adverse reaction profile was similar to that observed in other approved indications.

Metastatic Renal Cell Carcinoma

  • Study BO17705: Grades 3-5 adverse reactions occurring at a >2% higher incidence in bevacizumab with interferon alfa (N=337) compared to placebo with interferon alfa (N=304), were fatigue (13% vs. 8%), asthenia (10% vs. 7%), proteinuria (7% vs. 0%), hypertension (6% vs. 1%; including hypertension and hypertensive crisis), and hemorrhage (3% vs. 0.3%; including epistaxis, small intestinal hemorrhage, aneurysm ruptured, gastric ulcer hemorrhage, gingival bleeding, hemoptysis, hemorrhage intracranial, large intestinal hemorrhage, respiratory tract hemorrhage, and traumatic hematoma).

Persistent, Recurrent, or Metastatic Cervical Cancer

  • Study GOG-0240: Grades 3 or 4 adverse reactions occurred at a higher incidence of ≥ 2% in patients receiving bevacizumab with chemotherapy (N = 218) compared to patients receiving chemotherapy alone (N = 222), were abdominal pain (12% vs. 10%), hypertension (11% vs. 0.5%), thrombosis (8% vs. 3%), diarrhea (6% vs. 3%), anal fistula (4% vs. 0%), proctalgia (3% vs. 0%), urinary tract infection (8% vs. 6%), cellulitis (3% vs. 0.5%), fatigue (14% vs. 10%), hypokalemia (7% vs. 4%), hyponatremia (4% vs. 1%), dehydration (4% vs. 0.5%), neutropenia (8% vs. 4%), lymphopenia (6% vs. 3%), back pain (6% vs. 3%), and pelvic pain (6% vs. 1%).

Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

  • Combination with carboplatin and paclitaxel, followed by Bevacizumab as a single agent, for stage III or IV disease following initial surgical resection (Study BO17705): Grades 3-4 adverse reactions occurring at a higher incidence (≥2%) in either of the bevacizumab arms vs. the control arm were fatigue (CPB15+ -9%, CPB15 -6%, CPP -6%), hypertension (CPB15+ -10%, CPB15 -6%, CPP -2%), thrombocytopenia (CPB15+ -21%, CPB15 -20%, CPP -15%) and leukopenia (CPB15+ -51%, CPB15 -53%, CPP -50%).
  • Combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (Study MO22224): Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving bevacizumab with chemotherapy (N = 179) vs. patients receiving chemotherapy alone (N = 181) were hypertension (6.7% vs. 1.1%) and palmar-plantar erythrodysaesthesia syndrome (4.5% vs. 1.7%).
  • Combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Bevacizumab as a single agent for platinum-sensitive recurrent disease (Study AVF4095g): Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving bevacizumab with chemotherapy (N=247) compared to placebo with chemotherapy (N=233) were thrombocytopenia (40% vs. 34%), nausea (4% vs. 1.3%), fatigue (6% vs. 4%), headache (4% vs. 0.9%), proteinuria (10% vs. 0.4%), dyspnea (4% vs. 1.7%), epistaxis (5% vs. 0.4%), and hypertension (17% vs. 0.9%).
  • Patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have not received more than one previous regimen of chemotherapy (Study GOG-0213): Grades 3-4 adverse reactions occurring at a higher incidence (≥ 2%) in patients receiving bevacizumab with chemotherapy compared to chemotherapy alone were hypertension (11% vs. 0.6%), fatigue (8% vs. 3%), febrile neutropenia (6% vs. 3%), proteinuria (8% vs. 0%), abdominal pain (6% vs. 0.9%), hyponatremia (4% vs. 0.9%), headache (3% vs. 0.9%), and pain in extremity (3% vs. 0%).

INDICATIONS

Metastatic Colorectal Cancer (mCRC)

  • JOBEVNE combined with intravenous fluorouracil-based chemotherapy for first- or second-line treatment of patients with mCRC.
  • JOBEVNE combined with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the second-line treatment of patients with mCRC who have progressed on a first-line treatment containing bevacizumab.

Limitations of Use: JOBEVNE is not approved for use if surgery was used as the primary treatment in patients with colon cancer which has not spread to other parts of the body.

First-Line Non-Squamous Non–Small Cell Lung Cancer (NSCLC):

JOBEVNE combined with carboplatin and paclitaxel is approved for first-line treatment in patients with unresectable, locally advanced, recurrent or metastatic NSCLC.

Recurrent Glioblastoma (rGBM):

JOBEVNE is approved to treat rGBM in adults.

Metastatic Renal Cell Carcinoma (mRCC):

JOBEVNE combined with interferon alfa, is approved to treat mRCC.

Persistent, Recurrent or Metastatic Cervical Cancer (CC):

JOBEVNE combined with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat patients with persistent, recurrent, or metastatic cervical cancer.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer:

  • JOBEVNE combined with carboplatin and paclitaxel, followed by JOBEVNE alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection.
  • JOBEVNE combined with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
  • JOBEVNE combined with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by JOBEVNE alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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INDICATIONS

Metastatic Colorectal Cancer (mCRC)

  • JOBEVNE combined with intravenous fluorouracil-based chemotherapy for first- or second-line treatment of patients with mCRC.
  • JOBEVNE combined with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the second-line treatment of patients with mCRC who have progressed on a first-line treatment containing bevacizumab.

Limitations of Use: JOBEVNE is not approved for use if surgery was used as the primary treatment in patients with colon cancer which has not spread to other parts of the body.

First-Line Non-Squamous Non-Small Cell Lung Cancer (NSCLC):

JOBEVNE combined with carboplatin and paclitaxel is approved for first-line treatment in patients with unresectable, locally advanced, recurrent or metastatic NSCLC.

Recurrent Glioblastoma (rGBM): 

JOBEVNE is approved to treat rGBM in adults.

Metastatic Renal Cell Carcinoma (mRCC): 

JOBEVNE combined with interferon alfa, is approved to treat mRCC.

Persistent, Recurrent or Metastatic Cervical Cancer (CC): 

JOBEVNE combined with paclitaxel and cisplatin or paclitaxel and topotecan, is approved to treat patients with persistent, recurrent, or metastatic cervical cancer.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer:

  • JOBEVNE combined with carboplatin and paclitaxel, followed by JOBEVNE alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection.
  • JOBEVNE combined with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
  • JOBEVNE combined with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by JOBEVNE alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.