Cancer Patients to Get Access to World's 2 Best Drugs Soon


Merck's Keytruda gets DCGI nod, Bristol-Myers Squibb's Opdivo secures clinical trial waiver

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-Myers 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 (DCGI) 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. It directed the company to submit the data at twelve months from the date of approval of the clinical trial protocol.

Opdivo was given similar recommen dations by the SEC at its meeting in February but the committee added a caveat that the drug maker will need to submit its phase four data within six months of marketing in India.

Aphase four study , also termed post-marketing surveillance, is conducted for data related to the response of the patients to the drug. The SEC's recommendation had been backed by the apex committee in its meeting held in April. The committee comprises the highest ranking officials in the health ministry and reviews decisions by the SEC and the technical committee.

Noting that Keytruda was accorded priority review by US FDA and EMA (European Medicines Agency) given its potential impact on public health, a spokesperson for MSD India told ET, “We look forward to making available to patients this much needed product at an accelerated time line in the country and also work on addressing access barriers with a comprehensive approach.“

A spokesperson for BMS declined specific comments on the plans for Opdivo.He said BMS' future strategy in India will continue to be aligned with BMS global strategy . We are committed to ensuring that Indian patients can benefit from our innovative portfolio.

The two firms declined to share their pricing or marketing strategies for India. However, a city-based clinical oncologist hoped the two companies planned a tiered pricing approach, a step to help a swathe of patients in the lower income categories who can benefit from the drug.

In developed markets like US, where patients are reimbursed through well devised insurance plans, the two drugs are priced at approximately $145000 for a year-long supply. In India, however, global companies follow a much lower pricing policy to match the paying power locally.

Source: http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/breakthrough-cancer-drugs-all-set-for-india-launch/articleshow/53515688.cms

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