Roche's new oral lung cancer treatment Tarceva has received marketing approval in Europe.

Tarceva (erlonitib) is the first next-generation treatment for non-small cell lung cancer (NSCLC) to win EU approval after AstraZeneca's similar Iressa failed to significantly prolong lives of patients.

Analysts expect Tarceva to reach £800 million in peak sales, but could exceed this figure if it is approved for further indications.

"Tarceva takes lung cancer treatment a step forward, providing patients, whose treatment options are limited, with not only an extended life but one of better quality," said William Burns, chief executive of Roche's Pharma division.

"Its approval across the EU is a continuation of our commitment to ongoing research in the oncology field, with the aim of improving the health and quality of life for people with these devastating diseases."

Tarceva has been approved to treat patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen.

The approval was based on a phase III clinical trial of 731 patients with advanced NSCLC that saw Tarceva patients achieve a 42.5% improvement in median survival compared to those receiving a placebo.

The Tarceva group lived significantly longer than those patients on placebo and also saw improvements in the time before their disease symptoms deteriorated and the time when they were stable with no progression of their cancer.

NSCLC is the most common form of lung cancer, accounting for almost 80% of the 370,000 people suffering from it each year in Europe. It also has a very high mortality rate and few treatment options.

Tarceva was approved in the US in November last year and Switzerland in March. Roche has also filed for a US approval of Tarceva for advanced pancreatic cancer.

OSI Pharmaceuticals originally developed the drug before licensing it to Roche and Genentech, the Californian biotech company in which Roche has a majority stake, who market the product in the US.

Tarceva is one of a new EGFR-inhibitor class of drugs that target genetic mutations which allow cancer cells to multiply, and is designed to bypass many of the unpleasant side-effects associated with traditional chemotherapy.

Other drugs that work on the same principle of blocking the epidermal growth factor receptor include ImClone's colorectal cancer drug Erbitux and AstraZeneca's Iressa.

Iressa's prospects were hit in June when the FDA severely restricted its access on the grounds it did not help patients live longer.

The decision came after a large-scale trial of AstraZeneca's drug last year showed it to be no better than placebo at prolonging the lives of lung cancer patients and the new restrictions clear the way for Tarceva to be the first treatment of its kind to be approved for NSCLC in Europe.

AstraZeneca is still researching subgroups of patients, such as Asian patients and non-smokers, who may benefit from taking the drug.

A number of companies are developing new NSCLC treatments, including GSK, Sanofi-Aventis and Wyeth, who all have compounds currently in phase II.

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Tuesday , July 19, 2005

pharmafocus@wiley.co.uk