Roche receives negative opinion from European Committee for pancreatic cancer treatment Tarceva

By Lisa Kerner

Charlotte, N.C., July 28 - Roche said its cancer medicine Tarceva (erlotinib) has received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) for use in combination with gemcitabine chemotherapy for the first-line treatment of advanced pancreatic cancer.

Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor pathway.

While Roche said it is confident in its data showing the Tarceva combination treatment significantly increases patient survival, it will consider all options, including requesting a re-examination of the decision.

Tarceva has already been approved by the Food and Drug Administration for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy, according to a company news release.

The U.S. and E.U. applications were both based on data from the same phase 3 randomized study (PA32) of 569 patients conducted by the National Cancer Institute of Canada Clinical Trials Group.

Results demonstrated that treatment with Tarceva plus gemcitabine resulted in significantly longer survival (22%) compared to gemcitabine alone.

Roche is a research-focused health care group based in Basel, Switzerland,

© 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.