MSD launches blockbuster cancer drug Keytruda in India

NEW DELHI: US biopharmaceutical giant Merck, Sharpe and Dohme (MSD) has launched its blockbuster cancer drug ‘Keytruda’ (pembrolizumab) in India around a year after it first received approvals to market it, said persons aware of the development. The drug has so far only been approved here for a less prevalent type of cancer, while it is marketed in countries like the US to treat additional indications like a specific kind of lung cancer.

Keytruda, hailed as a ‘gamechanger’ therapy in oncology, is expected to help the immune system identify and selectively combat only cancerous cells instead of aggressively attacking cancer cells and risking healthy tissues in the process like existing therapies. The drug generated global sales of $1.4 billion during 2016.

The Drug Controller General of India (DCGI) gave MSD permission to market Keytruda in June 2016, according to minutes of the regulator’s Subject Expert Committee on oncology and haematology.

A person close to the development said the company had applied for approvals in India for unresectable or metastatic melanoma — types of malignant skin cancers that either cannot be removed by surgery or have spread to other parts of the body. In countries like the US, Keytruda is approved for other types of cancers, including non-small cell lung cancer (NSCLC).

Keytruda is expected to be 30% cheaper than the global prices and cost Rs 3.75-4.5 lakh for each dose here, according to two industry insiders who spoke to ET on condition of anonymity. The drug was launched in the US in 2014 at a price of reportedly $12,500 for each patient monthly or $150,000 annually. MSD did not respond to ET’s queries about the roll-out and pricing by the time this story went to press.



Oncologists expect MSD to approach the apex drug regulator to extend its approval for Keytruda to additional indications, including NSCLC, now that it has launched the product here.

“The results of key trials (with Keytruda) are so robust and encouraging,” said Dr Sachin Almel, consultant medical oncologist, Hinduja Hospital and Medical Research Centre, Mumbai. He expects MSD to soon apply for approvals for at least NSCLC as well.

Incidence of melanoma in India is less than 1% compared to other cancers, according to Almel. In comparison, NSCLC is “fairly common” and contributes to roughly 3-5% of all cancers in the country, he added.

At the same time, the potentially ‘breakthrough’ drug may not be able to create much impact because it is too expensive.

“Only one in 1,000 of my patients can actually afford to use this drug,” said an oncologist who spoke to ET on condition of anonymity.