FDA decision for glioblastoma comes after drug missed endpoint in Phase III early-stage colon cancer setting.

Genentech and Roche’s Avastin portfolio received some better news today compared to the recent Phase III failure. FDA approved the drug in a fourth tumor type: glioblastoma.

Avastin is now indicated for people with progressive brain cancer following prior therapy. The decision was made under the agency’s accelerated approval program and based on an improvement in objective response rate. Currently, no data is available from randomized controlled trials demonstrating an improvement in disease-related symptoms or increased survival with Avastin in glioblastoma.

Roche logged 5.2 billion Swiss francs, or $4.5 billion, last year from Avastin sales. The drug is already indicated for the first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy; for the first-line treatment of unresectable, locally advanced, recurrent or metastatic, nonsquamous, non-small-cell lung cancer in combination with carboplatin and paclitaxel; and for previously untreated, metastatic, or locally recurrent HER2-negative breast cancer in combination with paclitaxel.

Genentech and its new parent company, Roche, had high hopes for Avastin in early-stage colon cancer. A couple of weeks ago, though, the companies reported that Phase III data showed that the drug would not reduce cancer reappearance when combined with chemotherapy following surgery.

Roche is waiting to hear back from the FDA regarding first-line metastatic renal cell carcinoma and is preparing to submit for first-line HER2-negative metastatic breast cancer.

Still in the pipeline for Avastin is a Phase III trial in patients with newly diagnosed glioblastoma, says Hal Barron, M.D., evp, global development and CMO, Genentech. Other programs include testing Avastin in breast, colon, gastric, ovarian, stromal, prostate, and colorectal cancers as well as lymphoma in various combinations and settings.

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