Roche ($RHHBY) nabbed a first-line approval for Avastin in brain cancer. Japanese regulators cleared the drug to treat aggressive brain tumors, including newly diagnosed glioblastoma, as monotherapy and in combination with radiation and chemo. It's the first new drug in 8 years for first-line treatment of this form of brain cancer, the company says.
Ironically, the Japanese approval follows some disappointing data on Avastin in brain cancer, presented at the American Society of Clinical Oncology meeting earlier this month. As Genetic Engineering News points out, the study showed that Avastin combined with radiation and temozolomide chemo didn't significantly improve overall survival.
Japanese regulators based their decision on data from that trial, AVAglio, as well as two Phase II studies, one of them conducted in Japan. The approval comes just one month after the country's regulatory agency designated Avastin an orphan therapy in brain cancer. About 1,700 patients are diagnosed with malignant glioma and glioblastoma per year, Roche says.
Meanwhile, the company is waiting on decisions from European and Swiss regulators on Avastin as a first-line therapy in brain cancer. Avastin is approved in the U.S. to treat brain cancer patients whose disease has progressed after prior treatment. It's also approved for a host of other indications in the U.S. and elsewhere, including colorectal and lung cancers, and just won European approval in ovarian cancer. Avastin remains one of Roche's biggest sellers and is back to growth after losing its breast cancer indication in the U.S. in 2010. First-quarter sales amounted to ₣1.527 billion (francs), or about $1.64 billion, an increase of 11% year over year.
- read the release from Roche
- get more from GEN
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