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ODAC will Review Tarceva for Maintenance Therapy in Advanced Non-Small Cell Lung Cancer

Posted on: Tue, 17 Nov 2009 22:53:00 EST

Symbols: OSIP

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Nov 18, 2009 (Close-Up Media via COMTEX) --
OSIP | Quote | Chart | News | PowerRating -- OSI Pharmaceuticals, Inc. said that the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16, meeting.

The ODAC panel is a committee of external experts, formed by the U.S. Food and Drug Administration (FDA), to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer.

In June 2009, the FDA accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC who have not progressed following first-line treatment with platinum-based chemotherapy. In addition, the overall survival data was included in an update to the U.S. sNDA. The FDA Prescription Drug Fee Act (PDUFA) review date for the Tarceva application is on or about January 18, 2010.

OSI said that Tarceva is the only oral, non-chemotherapy agent shown to provide a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS) in the NSCLC maintenance setting.

Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cell, one of the critical growth factors in NSCLC and pancreatic cancers. Tarceva is indicated as a monotherapy for patients with locally advanced or metastatic NSCLC whose disease has progressed after one or more courses of chemotherapy. Tarceva is not intended to be used at the same time as chemotherapy for NSCLC.

Full Prescribing Information:

Call 1-877-TARCEVA or http://www.tarceva.com

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