
Opdivo and Keytruda set for India launches by end of year
pharmafile | August 8, 2016 | News story | Sales and Marketing | India, keytruda, launch, opdivo
Indian cancer patients could be set to receive two of the world’s leading oncology drugs, MSD’s Keytruda and Bristol-Myers Squibb’s Opdivo, by the end of this year according to the Economic Times.
Keytruda, which has consistently performed well in lung cancer and advanced melanoma,was recently approved the drug controller general of India, according to a top health ministry official.
Opdivo, on the other hand, recently received bad news as it failed to meet its primary endpoint as monotherapy in non-small cell lung cancer. However, it has consistently shown strong efficacy in combination with other treatments. Opdivo was said to have secured waiver from clinical trials a few months ago, which led to its marketing authorisation.
The accelerated approval of these immunotherapies has cut the usual time it takes for medicines to reach the market in India, with both drugs expected to be accessed by patients before the end of this year. While the local clinical trial requirement was waived for Opdivo, MSD will be required to conduct a post-marketing study in Indian patients for Keytruda.
Sean Murray
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