Chalk up another big win for Hal Barron and his R&D team extraordinaire at Genentech. The FDA today approved a new indication for Roche's ($RHHBY) cancer drug Avastin.
The drug is now approved as a second-line treatment for patients with metastatic colorectal cancer to be used in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy when their disease has progressed on a first-line Avastin-containing regimen, Fox News reports. The approval is based on a study the company released last year, which showed that patients who continued on the treatment after their cancer worsened lived longer than people who only received chemotherapy.
"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," said Barron, Roche's chief medical officer and head of product development. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."
Avastin is already one of the top selling drugs in the world, but researchers continue to find new ways the treatment can perform on cancers. In November, regulators in Europe approved it for treating women with recurrent, platinum-sensitive ovarian cancer in conjunction with standard chemotherapy with carboplatin and gemcitabine.
Barron and his group have had a number of big successes. Last year the FDA gave approval of the company's pertuzumab, allowing it to add the Herceptin companion drug to its cancer drug franchise. The drug, sold as Perjeta, carries a price tag of $5,900 a month, or about $71,000 a year, and is estimated to hit peak sales of $8 billion a year. Last month European regulators recommended it for approval there.
Also, Genentech's closely watched breast cancer drug T-DM1 is expected to receive approval in Europe in the first half of the year after hitting its primary endpoint for significantly improved overall survival among metastatic patients. The FDA had the chance to review T-DM1 after a promising Phase II trial but summarily rejected the application. Some analysts see the drug as being another huge seller like Avastin and Herceptin.
- read the Fox News story
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