Roche Holding AG (RHHBY - Free Report) has received priority review status from the FDA for supplemental Biologics License Application (sBLA) for Avastin plus chemotherapy. A response from the FDA should be out by Oct 24, 2014.
Roche is looking to expand Avastin’s label for the treatment of women suffering from persistent, recurrent or metastatic cervical cancer.
The FDA grants priority review status to medicines, which have potential to bring significant improvements in terms of safety or effectiveness in the treatment, diagnosis or prevention of serious diseases when compared to standard therapies.
According to the press release issued by Roche, cervical cancer causes more than 250,000 deaths across the world and is the fourth leading cause of cancer death in women. According to the American Cancer Society, more than 12,000 patients in the U.S. are expected to be diagnosed with cervical cancer in 2014 with nearly 4,000 expected to die from the disease.
Given that the survival rate falls to below one in six patients when the disease is metastatic, we believe there is urgent need for new treatment in this market. Approval for Avastin for this indication will increase the eligible patient population and boost Avastin sales significantly.
Avastin is already approved in several types of cancer with sales coming in at 6.3 million CHF in 2013, up 13% y/y.
According to the press release issued by Roche, chemotherapy is the only treatment approved for metastatic, recurrent or persistent cervical cancer. Some vaccines approved for protection against diseases caused by human papillomavirus (HPV) including cervical cancer are GlaxoSmithKline’s (GSK - Free Report) Cervarix and Merck’s (MRK - Free Report) Gardasil.
Roche carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is Allergan Inc. (AGN - Free Report) , carrying a Zacks Rank #2 (Buy).