Avastin Gains New Ovarian Cancer Indication

Genentech announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.

The new approval was based on results from the Phase 3 AURELIA study, a multicenter, randomized, open-label study that evaluated women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer, who had received no more than two anticancer regimens prior to start of the trial (n=361). Patients were randomized to one of six treatment arms (paclitaxel, topotecan, or pegylated liposomal doxorubicin with or without Avastin).

The study's primary endpoint was investigator-assessed progression free survival (PFS). Patients treated with Avastin + chemotherapy saw a median PFS of 6.8 months (95% CI 5.6, 7.8) vs. 3.4 months (95% CI 2.1, 3.8) in the chemotherapy alone group (HR 0.38, P<0.0001). The Avastin + chemotherapy group also demonstrated a hgiher median overall survival (OS), a secondary endpoint (16.6 months vs. 13.3 months; HR 0.89, 95% CI 0.69, 1.14).

RELATED: Combination Ovarian Cancer Therapy Granted Fast Track Status

Avastin, an angiogenesis inhibitor, is already approved for the treatment of the following cancers: persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy for first- or second-line treatment; or in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based therapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; glioblastoma, as a single agent for patients with progressive disease following prior therapy; and metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.

For more information call (800) 821-8590 or visit Avastin.com.

Loading links....