Mesothelioma Articles

Lilly Alimta Committee Review For Non-Small Cell Lung Cancer Set For July 27

Posted: June 4, 2004

Source: FDA Advisory Comittee.com

Lilly's Alimta for second-line treatment of non-small cell lung cancer will be reviewed by FDA's Oncologic Drugs Advisory Committee on July 27.

Lilly Investor Relations Manager Heidi Straub previously announced that the company expected a meeting for the pemetrexed supplemental NDA by the fourth quarter.

The committee review will come close to the the expected 10-month user fee deadline for the sNDA of late August, early September. Lilly filed the sNDA in late October or early November.

FDA has been mixed in its decisions to hold advisory committee meetings prior to initial approval for the latest novel cancer treatments. The agency convened a meeting for AstraZeneca's Iressa (gefitinib) but not Bristol-Myers Squibb/ImClone's Erbitux (cetuximab).

This is a second indication for Alimta, which was approved Feb. 4 for the treatment of malignant pleural mesothelioma. Lilly said it is pleased with early uptake of Alimta; first quarter sales were $12 mil., including $7 mil. in initial stocking.

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