Avastin Shows Benefits in Phase III Ovarian Cancer Study
EU submission already filed by Roche, and Genentech expects to file with FDA this year.!--h2>
A third Phase III study has demonstrated that treating ovarian cancer using Avastin and chemotherapy followed by Avastin alone significantly increases progression-free survival time compared with treatment using chemotherapy alone. The Oceans study included 484 women with platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer.
Results build on those from the previous GOG 0218 and Icon 7 studies in women with newly diagnosed ovarian cancer. Genentech says it now plans to submit applications to FDA for the use of Avastin in ovarian cancer during 2011. Roche has already submitted a marketing authorization application to the EU for the use of Avastin in the front-line setting based on data from the GOG 0218 and Icon 7 studies. A regulatory decision is expected later this year.
Participants in the Ocean study had received no more than one treatment prior to enrollment in the study. Patients were randomized to receive Avastin or placebo in combination with carboplatin and gemcitabine chemotherapy, followed by either Avastin monotherapy or placebo until disease progression.
Avastin was first approved in the U.S. back in 2004 for the treatment of advanced colorectal cancer. The drug is currently approved in the U.S. and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer, and kidney cancer. Approval in the U.S. and over 25 other countries has in addition been granted for the treatment of glioblastoma.
Roche says that over 500 clinical trials are ongoing to evaluate Avastin in over 50 tumor types and in different settings including advanced and early-stage disease.
Avastin was Roche’s biggest-selling pharmaceutical in 2010, with sales of nearly $6.5 billion representing a 9% increase on 2009. However, in December 2010, ongoing concerns about the drug’s use in the treatment of breast cancer led FDA to initiate the process of withdrawing Avastin’s approval for first-line treatment of metastatic breast cancer, and the EMA’s CHMP to recommend significantly limiting its licensed use in the breast cancer setting.