Roche, Genentech and OSI Pharmaceuticals have submitted applications to get expanded approval for the oncology blockbuster Tarceva on both sides of the Atlantic.

Genentech and OSI have submitted a supplemental New Drug Application to the US Food and Drug Administration for the use of Tarceva (erlotinib) as a first-line maintenance therapy for people with advanced non-small cell lung cancer who have not progressed following first-line treatment with chemotherapy. At the same time, Roche, which is in the process of buying the 44.2% stake in Genentech it does not already own, has filed a similar application with the European Medicines Agency.

The submissions are based on the Phase III trial known as Saturn which showed that Tarceva significantly extended the time patients with advanced NSCLC lived without their cancer getting worse when given immediately following chemotherapy, compared to placebo. The companies noted that there were “no new or unexpected safety signals” and the Saturn data will be presented at the American Society of Clinical Oncology meeting in Orlando at the end of May. Overall survival data, a secondary endpoint of the study, are expected in the second half of 2009 and will be part of the FDA review process.

OSI chief executive Colin Goddard said that if approved, Tarceva will be the first epidermal growth factor receptor targeted and oral therapy available as a first-line maintenance treatment for people with NSCLC. “We believe [it]is an important advancement in the treatment of lung cancer," he added.

Tarceva is already approved as a secondary treatment for NSCLC and a first-line treatment for pancreatic cancer. Sales of the drug this year are expected to reach $1.2 billion this year.

Teva, Mylan sued over Tarceva generic
Meantime, OSI has filed two lawsuits in the USA against Teva Pharmaceutical Industries and Mylan who have filed abbreviated New Drug Applications to manufacture and market a generic version of Tarceva before three patents expire.

The filing of the suits restricts the FDA from approving those applications until May 18, 2012, ahead of an “adverse court ruling”, OSI said.