Roche seeks re-examination of CHMP opinion on Tarceva in pancreatic cancer

By E. Janene Geiss

Philadelphia, Sept. 5 - Roche announced Tuesday that it has requested a re-examination of the data supporting the filing of its breakthrough cancer medicine Tarceva for the treatment of pancreatic cancer following the recent negative opinion from the European Committee for Medicinal Products for Human Use.

The filing was specifically for the use of Tarceva (erlotinib) in combination with gemcitabine chemotherapy for the first-line treatment of advanced pancreatic cancer. Pancreatic cancer is one of the most aggressive forms of cancer, killing more people within the first year of diagnosis than any other cancer, officials from the Basel, Switzerland, pharmaceutical company said in a news release.

Tarceva was granted a license by the Food and Drug Administration in November 2005 for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy.

Both the U.S. and the E.U. license applications are based on data from the phase 3 study that showed treatment with Tarceva plus gemcitabine results in significantly longer survival (22%) compared to gemcitabine alone.

Tarceva is being evaluated in an extensive clinical development program by a global alliance among OSI Pharmaceuticals, Genentech and Roche, focusing on earlier stages of non-small cell lung cancer.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.