Roche's Avastin has been in a bit of a slump after recent questions about its safety and efficacy in treating certain tumors, but the Swiss drug giant could get a boost with potential new approvals of the blockbuster drug in ovarian cancer.
Pascal Soriot, head pharma honcho at Roche, talked up the prospects of Avastin getting approved for ovarian cancer yesterday, telling members of the press that he expected the drug to gain approval for that indication in Europe with potential U.S. regulatory backing to follow.
Avastin, the first drug ever approved to inhibit the growth of blood vessels that feed tumors, is a big part what makes Roche the world's largest provider of cancer drugs. But revenue from the multi-billion-dollar seller used to treat multiple cancers has been hit by regulators' questions about whether the drug should be approved treatment for breast cancer. Eying a lucrative market for the drug, Roche aims to get European approval and file for a U.S. marketing green light in ovarian cancer later this year. Reuters reports.
"In Europe...we are pretty confident because typically in Europe you can gain approval on the basis of good progression-free survival data," Soriot said, as quoted by Reuters. "In the U.S., we still have to wait until the data are fully mature to see what the overall survival data look like and get a good sense for the FDA's response, but I have to say that what we have seen so far...is making us relatively optimistic that we have a good chance in the U.S. as well."
- check out the Reuters report
- read the article from MarketWatch