OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international partner for Tarceva
(erlotinib), Roche, received approval from the European Commission for Tarceva as a monotherapy maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged (stable disease) after platinum-based initial chemotherapy.
“We are pleased that the European health authorities recognize Tarceva as a valuable option for lung cancer patients and their physicians when used in the first-line maintenance setting,” said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “We look forward to working with our partner, Roche, to advance the robust Tarceva lifecycle program, which includes evaluating Tarceva in the adjuvant setting and as a first-line treatment for advanced NSCLC patients with an activating EGFR mutation as well as branching into other disease settings including liver cancer.”
OSI previously announced on April 16, 2010 that the U.S. Food and Drug Administration (FDA) approved Tarceva as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Tarceva is now approved in 109 countries for advanced NSCLC and 80 countries for pancreatic cancer.
The EU approval was based on data from the pivotal Phase III SATURN study. SATURN was an international, placebo-controlled, randomized, double-blinded, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress.
SATURN showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy significantly extended overall survival (OS) and significantly improved the time people with advanced NSCLC lived without the disease getting worse (progression-free survival, PFS) in a broad patient population, including squamous and non-squamous histology, compared with placebo.