OSI Pharmaceuticals said that the new approval for Tarceva was based on data from the pivotal Phase III Saturn study.
Saturn showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy 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.
Tarceva is already FDA-approved for people with advanced NSCLC whose cancer has grown or spread after receiving at least one course of chemotherapy. Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.
Colin Goddard, CEO of OSI Pharmaceuticals, said: “We believe that Tarceva, as the only medicine approved in the maintenance setting for the squamous and non-squamous forms of NSCLC, offers a valuable treatment option for these patients.
“We remain committed to a strategy of maximizing the value of Tarceva as an important therapy for cancer patients and are pursuing the study of additional uses for Tarceva, including as a first-line treatment for lung cancer patients with an activating EGFR mutation, as an adjuvant therapy in NSCLC, and in other tumor types such as ovarian cancer and hepatocellular carcinoma.”