Tarceva approved for pancreatic cancer in the US
Roche's Tarceva (erlotinib), the only EGFR-inhibitor to have shown a survival benefit in lung cancer, has been granted FDA approval in the US.
Roche's Tarceva (erlotinib), the only EGFR-inhibitor to have shown a survival benefit in lung cancer, has been granted FDA approval in the US.
Tarceva is the first new treatment in a decade that has shown a significant improvement in overall survival (23%) when added to chemotherapy.1 The FDA has approved Tarceva plus gemcitabine chemotherapy for the treatment of locally advanced, inoperable or metastatic pancreatic cancer.
Earlier in October, Roche submitted a Marketing Authorisation Application to the European health authorities for Tarceva to be used in combination with gemcitabine chemotherapy for the first-line treatment of patients with advanced pancreatic cancer.
Both the FDA approval and EU filing for Tarceva in pancreatic cancer are based upon the results of the pivotal Phase III randomised study (PA3) of 569 patients with locally advanced or metastatic pancreatic cancer conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University.
Tarceva is also approved in the US and across the EU for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. It is currently being evaluated in an extensive clinical development programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche, focusing on earlier stages of NSCLC. Additionally, Tarceva is being studied in combination with Avastin in NSCLC.
Trials are also being conducted with Tarceva in other solid tumours, such as ovarian, bronchioloalveolar (BAC), colorectal, pancreatic, head and neck and glioma (brain). Chugai is pursuing its development and regulatory approval for the Japanese market.