OSI Pharmaceuticals got stiff-armed by an FDA advisory committee, which voted 12-1 against broadening use of its cancer drug Tarceva. The company had wanted to market the pill as a first-line maintenance treatment after chemotherapy. Currently, Tarceva is approved for use in lung cancer patients when other treatments stop working. It's also approved for pancreatic cancer treatment.
The FDA's expert advisors weren't impressed by the 889-patient study OSI and partner Roche put forth to support the new indication. Half the patients--who had completed four courses of chemo without their cancer progressing--received Tarceva; the other half got a placebo. Tarceva patients had a median progression-free survival of 12.3 weeks, compared with 11.1 weeks in the placebo patients. "We all agree that if the overall survival benefit was larger ... we would be more impressed with that," said Wyndham Wilson of the National Cancer Institute (as quoted by Reuters).
The vote is especially significant for OSI because Tarceva is its only marketed drug; the company gets royalties from Roche's Genentech unit, which markets Tarceva in the U.S. Approval as a maintenance therapy could have added $400 million to annual sales, according to one analyst estimate quoted by Bloomberg. After the vote, though, J.P. Morgan analyst Geoffrey Meacham lowered his 2010 earnings estimate for the company, saying he expected other analysts to do the same. OSI execs were on a conference call responding to the vote at press time, so stay tuned.