Lilly Expects Alimta Advisory Committee Review For Non-Small Cell Lung Cancer
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is considering the pemetrexed sNDA for a July 27 Oncologic Drugs Advisory Committee meeting. First quarter sales of Alimta were $12 mil., including $7 mil. in initial stocking for the mesothelioma agent.
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Lilly expects its supplemental NDA for Alimta in second-line, non-small cell lung cancer will be the subject of an advisory committee meeting this year, Investor Relations Manager Heidi Straub said April 19. "As is customary with this type of submission, we anticipate the FDA to conduct an advisory panel," she said. "As a result, we expect a regulatory decision in the U.S. by the fourth quarter of this year." FDA is understood to be considering the sNDA for Alimta (pemetrexed) for its July 27 meeting of the Oncologic Drugs Advisory Committee. [Editor's Note: To 1 watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] The oncology committee also has a tentative meeting scheduled for September. Straub's comments on the approval timeline suggest that Lilly is expecting a 10-month review for the supplemental indication. Lilly filed the sNDA in late October or early November, putting a 10-month user fee deadline in late August or early September. Alimta was approved Feb. 4 for the treatment of malignant pleural mesothelioma (2 (Also see "Lilly Alimta To Be Available In Two Weeks Following Five-Month Review" - Pink Sheet, 5 Feb, 2004.)). Lilly said it is pleased with early uptake of Alimta; first quarter sales were $12 mil., including $7 mil. in initial stocking. - Kate Rawson |