MUMBAI: Cancer patients in India are set to gain faster access to two of the world’s best known new generation drugs – Keytruda from US based Merck and Bristol Myer Squibb’s Opdivo – both used to treat melanoma, a form of malignant skin cancer and a life-threatening lung cancer.
According to a top health ministry official, while Keytruda has recently been granted approval by the Drug Controller General of India in line with recommendations of expert oncologists and a powerful apex committee, Opdivo has secured waiver from clinical trials a few months ago, paving the way for its marketing authorization
The accelerated regulatory clearances cut the time lines for introductions of the two big brands which may be expected to be introduced by the end of the year, market sources indicated. Ever since their approvals by the US FDA in 2014, the two drugs have set new standards in cancer care, raising hopes of more breakthroughs in managing cancer patients. While most existing drugs aggressively attack cancer cells and in the process risk harming healthy tissues, Keytruda and Opdivo work differently, helping the immune system identify and selectively combat only the cancerous cells.
While Keytruda generated global sales of $566 million during 2015, Opdivo grossed $942 million, on course to reaching a blockbuster status.
Last November, a Subject Expert Committee (SEC) in India had granted import and marketing for pembrolizumab, branded Keytruda. It said the drug may be granted waiver of local clinical trial but put a condition of conducting phase four study in Indian patients
Source : Economic Times