Swiss pharmaceutical giant, Roche, and partners Genentech and OSI Pharmaceuticals, received a boost this morning after their cancer therapy, Tarceva (erlotinib), won its first European approval from the Swiss regulatory authority in the treatment of non-small cell lung cancer. Roche and Genentech already enjoyed a not insignificant rise in their share prices yesterday after Novartis and Schering AG revealed a delay to the regulatory filing of their key anti-cancer agent, PTK/ZK, which was tipped to be a competitor to the formers’ colorectal cancer drug, Avastin (bevacizumab) [[21/03/05a]].
Tarceva is specifically approved in Switzerland for the treatment of patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen, and won the green light in the US in this indication in November last year [[22/11/04d]]. Roche filed the product for Swiss approval in September 2004, with a dossier that included data from a pivotal Phase III clinical trial, in which patients with advanced NSCLC who were given the product as a second or third treatment option, had a 42% survival improvement compared with those in the placebo group [[07/06/04g]]. There was also a significant increase in both the length of time before disease symptoms deteriorated, and the time when patients were stable and there was no progression of their cancer. A 45% improvement in survival at one year was observed with Tarceva, with benefits being shown in a broad spectrum of patients.
Tarceva is an epidermal growth factor receptor therapy, which plays a role in numerous tumours, and is being investigated in a variety of other indications, including first-line NSCLC and pancreatic cancer [[30/11/04f]], [[28/01/05g]].
- Meanwhile, Roche says it has launched a new study to evaluate treatment options to reduce post-transplant recurrence of hepatitis C infection with the company’s combination therapy, Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). In the US, hepatitis C is the leading cause of liver transplantation.
The 300-patient trial will compare prophylactic combination therapy with Pegasys and Copegus (to prevent the virus from attacking the transplanted liver), with the same combination therapy administered once hepatitis C infection recurs in the transplanted liver.