New York-The federal government on Friday showed green signal to biotech major Genentech Inc. for marketing its best selling drug Avastin as a medication for late stage breast cancer, a decision welcomed by some but condemned by others concerned about the efficiency and cost of the drug.

Previously the drug has been approved to treat colon and lung cancer. The Food and Drug Administration’s decision clears the way for doctors to recommend the drug for women who have metastatic breast cancer. In the past, doctors were prescribing avastin for such women on an unapproved or “off label” basis. Though it is a legal thing it makes insurance coverage less probable.

The FDA decision has been made following the claim by U.S. Biotechnology Company last week that a study of Avastin used with chemotherapy prolonged progression free survival significantly in patients with breast cancer.

The approval came as a surprise, as just 2 months ago; an FDA advisory panel recommended disallowing the usage of the drug for breast cancer. By a narrow margin of vote a committee of medical experts came to a conclusion that Avastin did not lengthen the living time of women with late stage breast cancer significantly. Avastin was tested combined with traditional chemotherapy drug, paclitaxel (sold under the name taxol).

Dr. David Schenkein, senior vice president and head of oncology in Genentech, when referring to the committee’s vote said “It was a split decision, and I feel the FDA took it into consideration”.

In the time between the panel’s vote and Friday’s decision, the company officials said that they worked closely with the FDA in order to attend to the concerns of the agency.

Dr. Lisa Bailey, a breast cancer surgeon said “I’m glad FDA officials are considering other aspects apart from survival. I feel it’s vital, as quality-of-life concerns have to be included”.

“This will give women more choice,” she added.

Genentech shares rose nearly 9 % in the extended trading as the majority of the industry watchers were expecting the Food and Drug Administration to either delay a decision or disallow the use of the medicine for breast cancer.

Avastin, which has been already approved to treat lung and colon cancer, is considered as Genentech’s most significant drug by Wall Street analysts. Avastin’s U.S. sale was $2.3 billion in 2007 and an analyst estimates that its use for treatment of breast cancer can add around $500 million a year.

Moreover, Genentech is hoping to file an application to obtain FDA approval for use of Avastin for renal cell cancer later this year.

Relevant Links:

• FDA approved Genentech’s Avastin for advanced breast cancer
• National Cancer Institute

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