FDA drug record/Cancer/Jobevne

FDA record · Cancer

Jobevne (bevacizumab-nwgd)

What FDA's own documents say about Jobevne: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.

Sponsor
Biocon Biologics Inc.
Application
BLA 761175
First approved
April 9, 2025
Status
Approved
Read from
10 FDA documents, 423 pages

What it is approved for

“Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of:”

Prescribing Information (Label) · PDF p. 2 · fda.gov ↗

Trials FDA reviewed

TrialClinicalTrials.govPhaseMentionsDocuments
NCI 06not given62 of 10

Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.

Results FDA reported

Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.

ORR

“Among the 595 patients with measurable disease, ORR was also significantly higher (30% vs. 12%, p-value < 0.0001, stratified CMH test).”

Prescribing information, original approval · PDF p. 33 · fda.gov ↗

30%12%p-value < 0.0001

Safety

Most common adverse reactions

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

Prescribing Information (Label) · PDF p. 2 · fda.gov ↗

Adverse events the documents discuss most

Dosing on the label

“The recommended dosage is 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel.”

Prescribing Information (Label) · PDF p. 5 · fda.gov ↗

“The recommended dosage is 10 mg/kg intravenously every 2 weeks.”

Prescribing Information (Label) · PDF p. 5 · fda.gov ↗

FDA documents read

DocumentDatePagesCopysha256
Approval letter761175Orig1s000ltr.pdfApril 16, 20256e3e11013cacd
Prescribing information, original approval761175s000lbl.pdfApril 25, 202545f295d68817f2
Approval Letter761175Orig1s000Approv.pdfAugust 7, 20269ef9a96606b48
Chemistry Review761175Orig1s000ChemR.pdfAugust 7, 202661bd86f9e42a94
Prescribing Information (Label)761175Orig1s000Lbl.pdfAugust 7, 202651ddca97811b42
Multi-disciplinary Review761175Orig1s000MultidisciplineR.pdfAugust 7, 2026112d0436d2f9039
Proprietary Name Review761175Orig1s000NameR.pdfAugust 7, 20268496d2789a885d
Officer/Employee List761175Orig1s000OEList.pdfAugust 7, 20262907609c10ae5
Other Action Letters761175Orig1s000OtherActionLtrs.pdfAugust 7, 2026113e8eabf09920
Other Reviews761175Orig1s000OtherR.pdfAugust 7, 2026428bcbe7438200

Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.

Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.

Every drug for Cancer · All disease areas