The approval by the Food and Drug Administration of Genentech Inc’s Avastin drove the value up the stock up
in premarket trading Monday.
Late Friday the FDA gave conditional approval to the drug, used to treat metastasized breast cancer.
Conditional approval is actually accelerated approval and surprised many since the drug does not extend life but shrinks tumors by choking off their blood supply. Avastin also has serious side effects such as heart attack, stroke and bleeding.
The agency will continue to review data from clinical trials. Full approval could come next year.
Last year an FDA panel recommended 5-4 against approval. Genentech officials say they worked closely with the FDA to address concerns and the company released positive new data from a clinical trial last week.
"The FDA has lowered the bar under pressure from the industry at a time when the FDA is under enormous pressure around its drug approvals," Barbara Brenner, executive director of Breast Cancer Action in San Francisco tells the San Francisco Chronicle.
Avastin is FDA approved but only for lung and colon cancer and is used off-label for advanced breast cancer. That makes insurance coverage less likely. The drug costs nearly $85,000 for an 11-month supply.
Patients making under $100,000 a year can apply for assistance from the South San Francisco company which caps costs at $55,000 a year for the drug.
The FDA's action could increase sales of the drug by at least a billion over the next three years analysts say. Breast cancer affects 1.2 million a year and kills a half million worldwide each year.
The stock rose to $5.65 or $77.25. On Friday, Genentech shares finished at $71.60.
Last year, Avastin sales at $2.3 billion surpassed Rituxan, another Genentech drug used for treating cancer. #