Lilly Alimta could get advisory committee

FDA is understood to be considering a July 27 Oncologic Drugs Advisory Committee review of Lilly's supplemental NDA for Alimta (pemetrexed) for use in second-line, non-small cell lung cancer. 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 malignant pleural mesothelioma (1"The Pink Sheet" Feb. 9, 2004, p. 20)...

FDA is understood to be considering a July 27 Oncologic Drugs Advisory Committee review of Lilly's supplemental NDA for Alimta (pemetrexed) for use in second-line, non-small cell lung cancer. 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 malignant pleural mesothelioma (¹ (Also see "Lilly Alimta $3,900 Per Course Of Therapy, Available In Two Weeks" - Pink Sheet, 9 Feb, 2004.), p. 20)....