Additional Indication for OSI Drug - Analyst Blog

Recently, OSI Pharmaceuticals (OSIP) received approval from the US Food and Drug Administration (FDA) for its lead product, Tarceva (erlotinib) as a maintenance therapy for patients suffering from non-small-cell lung cancer (NSCLC), whose disease has not worsened after multiple rounds of chemotherapy. The drug has been co-developed with Genentech, a part of Roche Holdings (RHHBY). 

Earlier, in March 2010, the European Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tarceva for the first-line maintenance of patients suffering from locally advanced or metastatic NSCLC. A final decision is expected shortly. 

The FDA approval was based on the late-stage SATURN (front-line maintenance therapy in NSCLC post-chemotherapy non-progressors) study. The international, placebo-controlled, randomized, double-blinded, study conducted by Roche enrolled 889 advanced NSCLC patients across approximately 160 sites worldwide. 

The study demonstrated a statistically significant improvement during the time patients live without their disease worsening. The study also met a key secondary point and was successful in extending overall survival in advanced NSCLC patients who received Tarceva. 

Tarceva, a small molecule inhibitor of the epidermal growth factor receptor (EGFR), is currently marketed for the treatment of patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen. The drug is also approved to treat advanced pancreatic cancer in combination with the chemotherapy agent, gemcitabine. 

Tarceva achieved global sales of over $1.2 billion in 2009. We expect sales to increase further following the recent approval for additional indication. According to estimates from the American Cancer Society, lung cancer is the leading cause of cancer death in the US, which killed approximately 159,000 people in 2009. NSCLC is the most common type of lung cancer.
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