FDA Approves Avastin for Platinum-Sensitive Recurrent Ovarian Cancer
Genentech announced that the Food and Drug Administration (FDA) has approved Avastin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin alone, for the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
A "platinum-sensitive" disease refers to a relapse that occurs ≥6 months following the last treatment with platinum-based chemotherapy.
The FDA approval was based on data from two Phase 3 randomized, controlled studies: GOG-0213 and OCEANS. The GOG-0213 study showed that adding Avastin to chemotherapy resulted in an overall survival (OS) difference of 5 months vs. chemotherapy alone (median OS: 42.6 months vs. 37.3 months; hazard ratio [HR] 0.84, 95% CI: 0.69–1.01 and HR 0.82, 95% CI: 0.68–0.996).
Both studies also demonstrated a significant improvement in progression-free survival (PFS). In the GOG-0213 study, women lived a median 3.4 months longer with no disease progression when adding Avastin to chemotherapy vs. chemotherapy alone (median PFS 13.8 months vs. 10.4 months, HR 0.61, 95% CI: 0.51–0.72). In the OCEANS study, PFS was significantly improved in patients who received Avastin in combination with chemotherapy vs. placebo in combination with chemotherapy (median PFS 12.4 months vs. 8.4. months, HR 0.46, 95% CI: 0.37–0.58; P<0.0001).
OS was not significantly improved with the addition of Avastin to chemotherapy (HR 0.95, 95% CI: 0.77–1.17) in the OCEANS study.
Avastin, an angiogenesis inhibitor, is already indicated to treat metastatic renal cell carcinoma (mRCC) in combination with interferon alfa; glioblastoma, as a single agent for patients with progressive disease following prior therapy; 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; persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan; platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in patients who received no more than 2 prior chemotherapy regimens, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan; and as first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel.