OSI Pharmaceuticals, Inc. and Genentech, Inc., announced that OSI submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of Tarceva (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Additionally, the companies announced that Roche, their international collaborator for Tarceva, filed an application in Europe with the European Medicines Agency (EMEA).
"If approved, Tarceva will be the first EGFR targeted and oral therapy available as a first-line maintenance treatment for people with NSCLC, which we believe is an important advancement in the treatment of lung cancer," stated Colin Goddard, Ph.D., chief executive officer of OSI Pharmaceuticals.
"The FDA application reflects our goal of extending the time people with advanced lung cancer live without their disease progressing following initial treatment with chemotherapy," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer.
Both the US and EU submissions are based on a pivotal phase III placebo-controlled, randomized, double-blind trial known as SATURN. In November 2008, OSI, Genentech and Roche announced that SATURN met its primary endpoint and showed that Tarceva significantly extended the time patients with advanced NSCLC lived without their cancer getting worse (progression-free survival or PFS) when given immediately following initial treatment with platinum-based chemotherapy, compared to placebo. There were no new or unexpected safety signals in the study and adverse events were consistent with those observed in previous NSCLC clinical trials evaluating Tarceva.
The SATURN study, conducted by Roche, enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with at least four cycles of standard first-line platinum-based chemotherapy and were then randomized to Tarceva or placebo if their cancer did not progress. The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, safety and an evaluation of exploratory biomarkers.
Tarceva is a small molecule designed to target the EGFR pathway, which is one of the factors critical to cell growth in NSCLC and pancreatic cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signalling pathway inside the cell.
Tarceva is FDA-approved for use as a monotherapy in patients with locally advanced or metastatic NSCLC whose disease has progressed after one or more courses of chemotherapy. Results from two, multi-centre, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.
Tarceva is also approved in combination with gemcitabine for the treatment of patients who have not received previous chemotherapy for locally advanced pancreatic cancer, pancreatic cancer that cannot be surgically removed or pancreatic cancer that has spread to distant body organs.
OSI Pharmaceuticals is committed to "shaping medicine and changing lives" by discovering, developing and commercializing high-quality, novel and differentiated personalized medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA.