Drug maker Genentech (DNA.SW) Tuesday said its brain tumor drug Avastin was recommended unanimously by the Oncologic Drugs Advisory Committee of the US Food and Drug Administration for accelerated approval, as the committee found the response of the drug in people with pretreated glioblastoma as meaningful enough.
Glioblastoma is a form of tumor that invade brain cell, which generally becomes fatal within six-months, and affects nearly 10,000 people every year in the United States.
The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009. The FDA generally follows its panels' advice and has already approved Avastin for the treatment of advanced blood, lung and colorectal cancers.
David Schenkein, Senior Vice President, Clinical Hematology and Oncology said, We look forward to working with the FDA to potentially provide people with this devastating disease the first new treatment in more than a decade.
Genentech said the clinical trial showed that around 43% of the patients treated with Avastin lived six months without their disease getting worse, while half of the patients survived least 9.3 months with 38% living more that a year.
The test also found that the tumors shrank to at least half their original size in 28%. The test enrolled around 167 patients.
Genentech sought accelerated approval for Avastin following a Phase II BRAIN study evaluating Avastin alone or in combination with irinotecan with objective response rate and six-month progression-free survival as the primary endpoint. Secondary endpoints included overall survival and safety.
Genentech also noted that the most common severe adverse events in patients treated with Avastin alone were high blood pressure and seizures. There were two deaths associated with adverse events in the group of patients treated with Avastin alone.
As a serious side effect of the treatment, the company noted that Avastin could result in GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. The drug could also cause severe bleeding in lung cancer patients and might cause problems in getting pregnant.
Genentech, on March 26, 2009, was acquired by Swiss drug giant Roche Holding AG (RHHBY.PK, RHHVF.PK), for about $46.8 billion in which Genentech becomes a wholly-owned member of the Roche Group. The deal, expected to create the seventh largest U.S. pharmaceuticals company, is projected to be accretive to Roche's earnings in the first year after closing.
Avastin is currently sold by Roche outside of the US, while Genentech markets these in the U.S. Roche derives nearly 40% of its sales from Genentech's drugs.
RHHBY.PK closed Tuesday's regular trading at $34.40, up $1.34 or 4.05%, on the OTC. In the last 52-week period, the stock traded in the range of $79.09 to $99.00, on a three-month average volume of 0.21 million shares.
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