The world’s second largest drug maker, GlaxoSmithKline Plc., has started clinical trials on Indian patients to study if Tykerb, its new breast cancer drug, is effective in treating cancers of the brain as well as head and neck.
Specific treatment options for these cancers are limited in India and cancer hospitals resort to traditional methods of surgery or chemotherapy.
Tykerb, or lapatinib in its chemical form, was launched in the domestic market in early May at a 25% discount to the price it sells in the US and Europe (some $2,900, or Rs1.24 lakh, for a three-week treatment course).
It is used as a second-line treatment for breast cancer patients who don’t respond to primary drugs such as Herceptin (chemical name: trastuzumab) of Swiss drug maker F Hoffman-La Roche Ltd.
Clinical trials typically involve the testing of a new drug on humans after successfully proving that the chemical or “bio-pharmaceutical” has the potential to cure a disease or control a disorder, and that tests on animals show no adverse reactions. In the Tykerb case, the trials are being conducted for testing its efficacy in treating the other forms of cancer.
The trials of the drug for breast, and head and neck cancers are part of the company’s global clinical development programme for Tykerb, which includes sites within India, said a London spokesperson for GlaxoSmithKline. “It is too early to comment on the results since the study results are not yet published,” he said on email. Glaxo’s global study on other cancers is important for India as the country is one of the largest cancer prevalent regions in the world.
India has close to 2.5 million cancer patients, of which a majority are diagnosed for cervical and oral cancers, said Y.K. Sapru, chairman and chief executive of Mumbai-based Cancer Patients Aids Association. Head, and neck and brain cancers account for about 10% of these cases, he said.
“New studies are welcome in India, but they don’t often convert into a benefit for the country unless they prove effective and affordable to a majority of patients,” Sapru said.
Tykerb is a speciality treatment option available to breast cancer patients as 20-30% of them develop resistance to first-line treatments.
Data from the Indian Council of Medical Research shows that one in 22 women in India are prone to breast cancer.
According to various estimates, the market for cancer drugs in India is valued at about Rs900 crore and is expected to grow to more than Rs3,000 crore over the next five years. The Tykerb study could help terminally-ill cancer patients, if they enroll in the clinical trials, offering a chance of prolonging life even if not curing the disease, a cancer specialist in Mumbai said.
“In a way, this kind of study helps local patients, who normally go to medical consultation at the last stage,” said the Mumbai doctor, asking not to be identified. “Since Tykerb has already been approved for studies for different indications, including brain tumour, in many other countries, a new treatment choice will be available to Indian patients as well,” the doctor added.