Roche’s Tarceva approaches EU approval
pharmafile | June 28, 2005 | News story | Sales and Marketing |
Roche's new oral cancer treatment Tarceva has received a recommendation from the EMEA's advisory committee, paving the way for its EU approval.
Tarceva is the first treatment of its kind for non-small cell lung cancer (NSCLC) to reach this milestone after AstraZeneca's Iressa, a similar drug for lung cancer, faltered in trials.
William Burns, chief executive of Roche's Pharma division, said: "This decision is proof of the impressive survival benefit that Tarceva offers patients with late stage lung cancer."
The CHMP recommended Tarceva be indicated to treat patients with locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen.
The recommendation 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.
Non-small cell lung cancer 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 for use 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 class of cancer 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.
Current patients who have improved with the drug can continue to take it, but new patients will have to enrol in clinical trials that consider Iressa experimental. AstraZeneca is still researching subgroups of patients, such as Asian patients and non-smokers, who may benefit from taking the drug
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.
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