After promising last month to fast track its review of Roche's Avastin in cervical cancer, the FDA has come back with a positive verdict--a full two months before its deadline. The agency approved the blockbuster drug to be used in combination with chemotherapy in women with advanced cervical cancer.
Roche has won FDA approval for its HPV test used for primary screening of cervical cancer. The regulatory nod is expected to increase the company's profile in the U.S. and grow its 20% share of the global diagnostics markets.
Cepheid announced Wednesday it has released Xpert HPV for sale in Europe. The fast test is designed to detect cervical-cancer-related human papillomaviruses (HPV) in women and return results in an hour.
In another win for Roche, a panel of experts unanimously recommended that the company's HPV test could be used for primary screening of cervical cancer.
Roche is aiming to make its human papillomavirus test a first-line diagnostic for cervical cancer, with a new FDA application for the Cobas HPV as a substitute for Pap tests.
Quest Diagnostics and Hologic inked a 5-year strategic deal calling for the companies to jointly develop and promote new women's health diagnostic products.
Roche took two steps forward and one step back on the Avastin front today, as investigators laid out a clear advantage in adding the therapy to chemo for cervical cancer while finding no survival advantage when adding it to first-line treatment of an aggressive form of brain cancer.
Social issues have held back uptake of GlaxoSmithKline and Merck human papillomavirus (HPV) vaccines in the U.S., but globally the problem is more fundamental--the shots cost too much. It is these low-income countries--where 85% of cervical cancer cases occur--that need the vaccines most though.
Merck and GlaxoSmithKline have some persuading to do. A growing share of U.S. parents say they won't vaccinate their daughters against human papillomavirus, which causes cervical cancer. And that leaves Merck's Gardasil and GSK's Cervarix with a shrinking market.
Could Avastin be on its way to another indication? On the heels of a broader approval for the drug in ovarian cancer in the EU, the U.S. National Institutes of Health has unveiled data showing Avastin helped patients with advanced cervical cancer live longer.