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FDA Approves Avastin for Advanced Ovarian Cancer

Genentech news release; 2016 Dec 6

The FDA has approved Genentech’s Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than 2 prior chemotherapy treatments. Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (psOC).

Dosage and administration:

  • Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer:
    • 10 mg/kg IV every 2 weeks with paclitaxel, pegylated liposomal doxorubicin or weekly topotecan.
    • 15 mg/kg IV every 3 weeks with topotecan given every 3 weeks.
  • Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer:
    • 15 mg/kg IV every 3 weeks in combination with carboplatin/paclitaxel for 6-8 cycles, followed by 15 mg/kg IV every 3 weeks as a single agent.
    • 15 mg/kg IV every 3 weeks in combination with carboplatin/gemcitabine for 6-10 cycles, followed by 15 mg/kg IV every 3 weeks as a single agent.

Adverse reactions: The most common adverse reactions incidence are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.

Citation:

FDA approved Genentech’s Avastin (bevacizumab) plus chemotherapy for a specific type of advanced ovarian cancer. [news release]. South San Francisco, CA: Genentech; December 6, 2016: https://www.avastin-hcp.com/. Accessed December 8, 2016.