The Hindu Business Line : GSK to seek Drug Controller nod for breast cancer drug

Fast track nod
Though India does not have a system of fast-track approvals, drugs that target illnesses significant to India are given speedy approvals by the regulatory Drug Controller General of India (DCGI).

Mumbai March 14 GlaxoSmithKline (GSK) will seek regulatory approval in India to bring in its breast cancer drug lapatinib, sold under the Tykerb brandname.

Tykerb, in combination with Xeloda, is used in advanced breast cancer cases.

Earlier this week, it received fast-track US regulatory approval on this medicine.

The drug will be sold in the US within a fortnight, a company official said.

GSK will seek similar speedy regulatory approval under the "unmet medical need clause" to bring the medicine into India, said Dr Sadhna Joglekar, Vice-President, Medical and Clinical Research.

Though India does not have a system of fast-track approvals, drugs that target illnesses significant to India are given speedy approvals by the regulatory Drug Controller General of India (DCGI), she added.

Tykerb is a once-a-day oral treatment option for patients with advanced breast cancer and was granted `priority review' by the US Food and Drug Administration in November 2006.

If Tykerb does get quick approval in India, GSK would have to submit periodic safety update reports (PSUR), where the company would have to submit to the regulator data on adverse events related to the medicine.

This would have to be done every six months for the next two years, followed by every year for another two years, she told Business Line.

However, if the drug does not receive quick approval, the company would have to undertake late-stage clinical trials, where it would be given to patients and monitored for safety and efficacy.

Slated for launch in the US soon, the drug is in different stages of getting regulatory approvals to market in Europe, Australia, Korea and Canada, she said.

India has been involved with the global clinical development of the drug for applications of breast cancer and about four other indications, she said.

Clinical trails are already under way in six sites in the country, she added.

A clear picture on the pricing of the medicine in the US would emerge closer to the launch. In India, GSK will have to do some out-of-the-box thinking to keep the medicine accessible and affordable, she added.