 |
  
Pharmaceutical Jobs, Learning Resources, Career Tools
|
|
| ||||||||||||||||||||||||||||||||
|  |  Tarceva Now Approved for Advanced Non-Small Cell Lung Cancer and Pancreatic CancerPress Release November 3, 2005 MELVILLE, N.Y. and SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 2, 2005--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that the U.S. Food and Drug Administr ation (FDA) approved Tarceva(R) (erlotinib) in combination with gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy. Tarceva 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. Tarceva is a once-daily oral tablet already approved for use in patients with non-small cell lung cancer (NSCLC) whose disease has progressed after one or more courses of chemotherapy. OSI also announced that Roche, its international partner for Tarceva, has submitted a Marketing Authorization Application (MAA) 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," said Dr. Malcolm Moore, study chair and medical oncologist at Princess Margaret Hospital in Toronto, Canada, and Chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group. "Erlotinib represents a notable step forward for patients and healthcare providers in a disease with a very poor prognosis." 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 (PanCAN), a national patient advocacy organization for the pancreatic cancer community. "We welcome the approval of Tarceva as part of a combination therapy with gemcitabine for pancreatic cancer patients," said Julie Fleshman, president and CEO of PanCAN. "The disease is incredibly deadly with most patients not surviving past one year. For years, treatments for pancreatic cancer have lagged behind other cancers so the availability of Tarceva means patients now have more treatment options as they make informed decisions." "Tarceva is the first FDA approved therapy in nine years to demonstrate an improvement in overall survival and we are pleased that pancreatic cancer patients now have a new treatment option with a proven survival benefit," said Gabe Leung, President of (OSI) Oncology at OSI Pharmaceuticals. "In addition, the submission of Tarceva for pancreatic cancer in the European Union underscores the commitment of the OSI/Genentech/Roche alliance to make Tarceva available to cancer patients around the world as soon as possible." "Advanced pancreatic cancer and non-small cell lung cancer are two of the most difficult-to-treat cancers, and Tarceva, which targets the EGFR/HER1 pathway, has now been shown to increase survival in both these cancers," stated Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. "We continue to study Tarceva in other cancers and in combination with other therapies."
About hireRx
::
Copyright ::
Privacy
:: Legal
:: Contact |
 |
|
 |
Print
This Page