FDA Approves Bevacizumab with Chemotherapy for Ovarian Cancer

Officials with the FDA have approved bevacizumab (Avastin, Genentech) in combination with carboplatin and paclitaxel for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.

The recommended bevacizumab dose is 15 mg/kg every 3 weeks with carboplatin and paclitaxel for up to 6 cycles, followed by 15 mg/kg every 3 weeks as a single- agent, for a total of up to 22 cycles.

Bevacizumab was approved as an orphan product based on GOG-0218, a multicenter, randomized, double-blind, placebo-controlled, 3-arm study evaluating the addition of bevacizumab to carboplatin and paclitaxel for patients with stage III or IV epithelial ovarian,

fallopian tube, or primary peritoneal cancer,

following initial surgical resection. Adverse effects experienced by at least 5% of patients receiving bevacizumab were diarrhea, nausea, stomatitis, fatigue, arthralgia, muscular weakness, pain in extremity, dysarthria, headache, dyspnea, epistaxis, nasal mucosal disorder, and hypertension. Grade 3-4 adverse effects occurring ≥2% of patients in either of the bevacizumab arms versus the control arm were fatigue, hypertension, platelet count decreased, and white blood cell count decreased.

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