indiaflag

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.

Advertisement

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

Related Content

Bristol Myers Squibb receives positive CHMP opinion for Opdivo treatment

Bristol Myers Squibb (BMS) has received a positive opinion from the Committee for Medicinal Products …

CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma

Merck (known as MSD outside of the US and Canada) has announced that its anti-PD-1 …

Merck shares data from phase 3 trial of Keytruda for TNBC treatment

Merck, known as MSD outside of the US and Canada, has announced results from the …

The Gateway to Local Adoption Series

Latest content