Tarceva receives approval for pancreatic cancer in the US
pharmafile | November 8, 2005 | News story | Sales and Marketing |Â Â Â
Roche and Genentech's Tarceva has been approved in the US for the treatment of pancreatic cancer – one of the most aggressive tumours, killing more people within the first year than any other.
Tarceva (erlotinib) has only just been launched in Europe for its first indication, the treatment of lung cancer, following its debut on the US market in November 2004.
Now Tarceva has become the first new treatment in a decade for pancreatic cancer to show significant improvement in overall survival when added to chemotherapy.
The FDA has approved Tarceva plus gemcitabine (Lilly's Gemzar) chemotherapy for the treatment of locally advanced, inoperable or metastatic pancreatic cancer.
Pancreatic cancer is the fifth leading cause of cancer deaths in the developed world and is the tenth most frequently occurring cancer in Europe with a death rate of approximately 78,000 people per year.
The cancer is difficult to treat because it is often resistant to chemotherapy and radiotherapy, tending to spread quickly to other parts of the body and leading to high mortality and short life expectancy.
Phase III trial results showed Tarceva plus gemcitabine in patients with advanced pancreatic cancer resulted in significantly longer survival – 23% – compared to gemcitabine alone, with nearly a quarter of patients receiving the combination alive one year later, compared to 19% on gemcitabine alone.
Roche submitted the drug combination for a European licence in October, with approval expected in early 2006.
Tarceva is currently in a wide range of trials to treat other cancers including other solid tumours such as ovarian, bronchioloalveolar (BAC), colorectal, pancreatic, head and neck and glioma (brain).
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Roche's Tarceva approved in Europe
Wednesday, September 21, 2005
