Tarceva gets negative opinion from CHMP

Swiss drug major Roche says that its anticancer agent Tarceva (eriotinib), developed in collaboration with US firm OSI Pharmaceuticals, has received a negative opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use. Specifically, the Committee said that the product should not be approved for use in combination with gemcitabine chemotherapy for the first-line treatment of advanced pancreatic cancer patients.

The drug, which is approved in both the USA and Europe for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have not responded to prior chemotherapy, received US Food and Drug Administration approval for the pancreatic cancer indication late last year (Marketletter September 19, 2005), which, Roche added, was based on the same data submitted to the CHMP.

In response, Roche said that it would now consider all options available to it, including requesting a re-examination of the Committee's decision. The firm added that it was still committed to gaining approval for the drug in numerous oncology indications, citing its Japanese subsidiary Chugai Pharmaceuticals' submission of a New Drug Application to the Ministry of Health, Labor and Welfare requesting approval for the product's use in the treatment of advanced or recurrent NSCLC, as an example of this strategy (Marketletter April 24).