FDA approval for Avastin in OC

FDA Approves Avastin for Recurrent Ovarian Ca
Published: Nov 14, 2014



By Charles Bankhead, Staff Writer, MedPage Today

WASHINGTON -- The FDA has approved the angiogenesis inhibitor bevacizumab (Avastin) for use in combination with chemotherapy to treat platinum-resistant recurrent ovarian cancer.
The approval was based on results of an international, phase III, randomized trial to compare chemotherapy alone or in combination with bevacizumab. Known as AURELIA, the trial involved 361 women whose ovarian cancer had recurred less than 6 months after their most recent platinum-based chemotherapy regimen.
The trial had a final endpoint of progression-free survival (PFS), and the results demonstrated a 62% reduction in the hazard for progression or death in patients who received bevacizumab. An analysis stratified by the type of chemotherapy showed a consistent benefit for the bevacizumab arm.

According to statements from the FDA and drug developer Roche/Genentech, AURELIA investigators had the option to use chemotherapeutic agents other than paclitaxel. An analysis stratified by the type of chemotherapy showed a consistent benefit for the bevacizumab arm.

The largest difference occurred when patients received bevacizumab in addition to paclitaxel, which resulted in almost a 6-month improvement in median PFS (9.6 versus 3.9 months, HR 0.47, 95% CI 0.31-0.72). The paclitaxel-bevacizumab combination also resulted in the greatest increase in overall survival (22.4 versus 13.2 months, HR 0.64, 95% CI 0.41-1.01).

In the bevacizumab group, adverse events occurring in ≥15% of patients were neutropenia, peripheral sensory neuropathy, and hypertension. Gastrointestinal perforation, a known risk associated with bevacizumab, occurred in 1.7% of patients who received the angiogenesis inhibitor.

The action represents the first approval of a new treatment option for platinum-resistant recurrent ovarian cancer in 15 years, according to drug developer Roche/Genentech. Earlier this year, FDA approved bevacizumab for use with chemotherapy to treat patients with advanced cervical cancer. Those two approvals add to bevacizumab's previously approved indications for colon cancer, lung cancer, and kidney cancer.
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So the FDA gave it's approval on the basis of improvement in PFS of around 6 months. I haven't been able to locate any final OS trial data for Avastin alone, but the combination with the chemo drug resulted in 9 month OS advantage. It was approved for sale in Europe a few months ago.

There are some significant side-effect issues but the authorities obviously feel the overall benefits outweigh these, due to the lack of treatment options in OC.

Apparently the treatment is selling at $70,000 p.a. and Roche reported income of $6 billion from Avastin (from the other indication for which it has previously been approved).

If Cvac trial results continue to show the kind of positive trend seen thus far, it makes a pretty compelling commercial case.