July 17, 2014 — FDA has granted priority review to Genentech's application to expand approval of the drug Avastin to include cervical cancer treatment, the San Francisco Business Times' "Biotechsf" reports.
According to "Biotechsf," priority review is granted to medications that could significantly improve a treatment's safety or effectiveness. In the case of Avastin, which is already one of the best-selling cancer drugs in the world, Genentech wants FDA permission to market the drug for use in conjunction with chemotherapy for women with metastatic, recurrent or persistent cervical cancer.
Currently, chemotherapy is the only option for those patients (Leuty, "Biotechsf," San Francisco Business Times, 7/15).
According to the Wall Street Journal, about 250,000 women worldwide die from cervical cancer annually, including nearly 4,000 deaths in the U.S. The disease is the fourth-highest cause of cancer death among women (Maclucas, Wall Street Journal, 7/15).
In a 452-woman clinical trial, women with cervical cancer who received both Avastin and chemotherapy lived an average of 17 months, compared with an average of 13.3 months for women who only received chemotherapy.
In addition, women who received both chemotherapy and Avastin had a longer time period before their disease worsened: an average of 8.2 months for women who received the combination treatment, compared with 5.9 months for women who received just chemo.
FDA in 2011 revoked approval of Avastin as a treatment for breast cancer, but it remains an approved treatment for certain types of colorectal, lung and kidney cancers. FDA could decide to approve or reject Avastin for use in cervical cancer treatment by Oct. 24 ("Biotechsf," San Francisco Business Times, 7/15).