The US FDA have approved Tarceva (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen in the United States, Roche, OSI Pharmaceuticals and Genentech have jointly announced here.
Tarceva is the first and only EGFR-targeted treatment to have shown a significant survival benefit in patients with NSCLC, improving survival by 42 per cent. EGFR is a key component of the human epidermal growth factor receptor pathway, which plays a role in the formation and growth of numerous cancers.
Tarceva is also currently under review for marketing authorisation with the European and other health authorities.
"Tarceva is the first treatment of its kind to have shown an impressive survival benefit in patients with advanced cancers," William M. Burns, head of Roche Pharmaceuticals Division said adding, "The speed of which the FDA has approved Tarceva is testimony to this. We are working closely with European and other regulatory authorities to bring this treatment to other patients as quickly as possible."
The FDA approval was based on results from the pivotal phase III randomised trial (BR.21) involving 731 patients, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva lived significantly longer than those in the placebo arm (6.7 months vs 4.7 months), an improvement of 42 per cent. There was also a significant increase in both the length of time before patients symptoms deteriorated and the time when patients were stable, and there was no progression of their cancer. In addition, there was a 45 per cent improvement in survival at one year and further analysis showed treatment benefit over a broad spectrum of patients, release from Roche said.