Pharmaprojects R&D Pipeline News Feed
Erbitux filed for non-small cell lung cancer in the US
18 Dec 2008
ImClone Systems and Bristol-Myers Squibb have submitted a US filing for approval of their anti-EGFR monoclonal antibody therapy, Erbitux (cetuximab) for the first-line treatment of advanced non-small cell lung cancer (nsclc) in combination with platinium-based chemotherapy.
The filing application is based on data from the Phase III FLEX trial in 1124 patients with stage IIIb or IV nsclc. In this trial, Erbitux in combination with cisplatin and vinorelbine increased survival by 1.2 months compared to chemotherapy alone, meeting its primary endpoint. In a second Phase III trial (BMS-CA225-099) in 600 advanced nsclc patients, Erbitux in combination with carboplatin and taxane therapy failed to meet the primary endpoint of progression-free survival.
Erbitux is already launched for both metastatic colorectal cancer (MCC) and head and neck cancer both in the EU and the US, with recent launches for MCC in Canada and Japan. If approved, nsclc would represent Erbitux' largest indication. Future approval may also offer hope to squamous cell cancer patients who are at present faced with limited treatment options due to the risk of pulmonary bleeding with Roche/Genentech's Avastin (bevacizumab).
Merck KGaA submitted a similar filing to the EMEA in September 2008, while a decision by the US FDA on whether to accept the new filing for review is expected in February 2009.
