OSI Pharmaceuticals (OSIP) received a setback recently with the US Food and Drug Administration (FDA) extending the review date of Tarceva (erlotinib), for its use as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) patients. Tarceva, OSIP’s lead product has been developed in collaboration with Genentech, a part of Roche (RHHBY).

While the original Prescription Drug User Fee Act (PDUFA) date was January 18, 2010, the FDA has extended it by another 90 days to April 18, 2010. The extension follows the submission of additional data in support of the original application. We were not surprised by the delay as the FDA Oncologic Drugs Advisory Committee (ODAC) voted 12 -1 recommending against the approval of Tarceva for this indication in December 2009.

In 2004, the FDA approved Tarceva for the treatment of patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen. Thereafter, in 2005, Tarceva was approved in combination with gemcitabine for the treatment of advanced first-line pancreatic cancer in patients who have not received previous chemotherapy.

According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the US (nearly 30%). NSCLC is the most common form of lung cancer, accounting for almost 80% of cases.

Last week, at the J P Morgan Healthcare Conference, OSI Pharmaceuticals reported $1.2 billion in 2009 global sales of Tarceva, representing an increase of 7% compared to the corresponding period last year. Tarceva is the key growth driver for OSI Pharmaceutical, representing 80% of total revenue in the third quarter of 2009. Given the situation, OSI and Genentech/Roche have been conducting several additional clinical trials that could help drive higher market penetration. Although the extension of review is a setback for the company, we believe it will work closely with the FDA to sort out the issues.

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