Roche unit Genentech announced Friday that the Food and Drug Administration approved the injectable drug Perjeta for women with a type of breast cancer known as HER-2 positive, which makes up about a quarter of all breast cancers and has no cure.
Analysts predict the medicine could be another blockbuster cancer drug for the Swiss company.
The FDA accepted the application for the drug under priority review, meaning the agency believes the drug may represent a potentially significant advancement over existing treatments. In clinical trials, the drug kept the cancer from worsening for 6 extra months, compared to the current standard of care.
Breast cancer, the most common cancer among women worldwide, will afflict about 227,000 U.S. women in 2012, and kill about 39,500 of them, according to the American Cancer Society.
Genentech, which developed Perjeta, suffered a blow last year when the FDA revoked approval for its blockbuster drug Avastin as a treatment for breast cancer, saying the drug was not effective enough to justify its risks.
At the time, FDA advisers and other experts said Genentech should have done more trials to see exactly which subset of breast cancer patients would most benefit from the treatment.
Roche said Perjeta, known generically as pertuzumab, would only be available for women who are diagnosed with the HER2-positive form of breast cancer.
Analysts polled by Thomson Reuters have on average forecast annual pertuzumab sales of $608 million by 2016 - though some say sales could eventually climb beyond $1 billion.
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