Good News for OSI Pharma – Analyst Blog

Recently, a European advisory committee recommended the approval of Tarceva (erlotinib) as a maintenance therapy for patients suffering from lung cancer following multiple rounds of chemotherapy. Tarceva is the lead drug of OSI Pharmaceuticals Inc. (OSIP). Tarceva has been co-developed with Genentech, which is now a part of Roche Holdings (RHHBY).

 

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 non-small-cell lung cancer (NSCLC). The European Commission is expected to give its decision on the matter within 45 days.

 

The favorable recommendation from the European advisory committee 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 non-small cell lung cancer (second line NSCLC) after the failure of at least one prior chemotherapy regimen and pancreatic cancer.

 

The U.S. Food and Drug Administration (FDA) is currently reviewing the drug for this additional indication. The U.S. regulatory authority recently extended the review period for the supplemental New Drug Application (sNDA) for the drug as a first-line maintenance therapy in advanced NSCLC by 3 months. The agency is expected to come to a decision by April 18, 2010.