OSI, Genentech get FDA approval for Tarceva to treat pancreatic cancer

By E. Janene Geiss

Philadelphia, Nov. 2 - OSI Pharmaceuticals, Inc. and Genentech, Inc. announced Wednesday that the U.S. Food and Drug Administration approved Tarceva in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy.

Tarceva (erlotinib) is the first drug in a phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy as initial treatment for pancreatic cancer, according to a company news release.

Tarceva is a once-daily oral tablet already approved for use in patients with non-small cell lung cancer whose disease has progressed after one or more courses of chemotherapy.

OSI also said that Roche, its international partner for Tarceva, has submitted a Marketing Authorization Application to the European Health Authorities for Tarceva for the treatment of pancreatic cancer.

"Improvements in therapy in advanced pancreatic cancer have been very difficult to come by. As a molecularly targeted agent, erlotinib has been shown to add a survival benefit when combined with gemcitabine for patients facing pancreatic cancer," Malcolm Moore, study chair and medical oncologist at Princess Margaret Hospital in Toronto and chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group, said in the release.

"Erlotinib represents a notable step forward for patients and health care providers in a disease with a very poor prognosis," Moore added.

Pancreatic cancer has the highest one-year mortality rate of any cancer. The average life expectancy for a patient diagnosed with metastatic pancreatic cancer is three to six months, according to The Pancreatic Cancer Action Network.

The FDA approved the drug based on results from a randomized double-blind, placebo-controlled phase III clinical study of Tarceva, in combination with gemcitabine chemotherapy in patients with unresectable locally advanced or metastatic pancreatic cancer. The study met its primary endpoint of improving overall survival, officials said.

Melville, N.Y.-based OSI developed the drug and markets Tarceva through collaborations with Genentech, which is based in South San Francisco, Calif.

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