Roche launches new lung cancer drug

It is an oral tablet taken once a day and has the potential to treat many types of solid tumors and the drug has been approved in the US since November 2004 and in the European Union since September 2005, Telang said.

The drug has demonstrated a striking survival benefit (42.5 per cent) in advanced non-small cell lung cancer, the most common form of the disease and has also shown to significantly improve patients' quality of life by alleviating the severe and debilitating symptoms that characterise advanced disease, such as cough, pain and breathlessness, Telang said.

Tarceva works differently to chemotherapy by specifically targeting tumor cells and inhibiting their growth. The drug blocks tumor cell growth by inhibiting the activity of a specific enzyme, tyrosine kinase, which is part of the human Epidermal Growth Receptor (EGR).

When asked whether the drug has been registered in the country, Telang said, the drug is a post-1995 patent and is in the mailbox in India since 1996. However, the company will conduct an Expanded Access Programme (EAP) with five cancer centres in the country and 25 patients will be given the treatment with the drug.

"This is a process we have undertaken before getting the official registration and marketing and distribution in the country. It is not clinical trial but treatment for the patients," Telang said adding the treatment will be given for three months after 25 patients have been selected.

"We have applied to the government for registration and expect it to come through by the end of this year," he said. About the cost of the treatment, he said the drug will be sold 40 per cent below the international cost and if the government removes the duty on the drug, then the price will be further reduced.

After taking the drug, the life of the patient extends upto a year, Telang

said. EAP is also going on other countries where the drug is not available and under this initiative tarceva will be available at 600 sites across 60 countries, he added.

During the treatment, the patients may develop a rash analysis of phase II studies with the drug suggested that the rash might be an indictor for drug activity, he pointed out. Asked whether the drug was tried on other types of cancer, Telang said, phase III trials when conducted for pancreatic cancer jointly with Genentech and OSI Pharmaceuticals, tarceva in combination with gemcitabine improved overall survival in patients.

"We are also focusing on trials on earlier stages of NSCLC and in combination with another anti-cancer drug of Roche 'avastin,' he added. Trials are on with traceva in other solid tumors like ovarian, brinchioloalveolar and colorectal, head and neck and glioma (brain), Telang said.

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