Merck & Co., Inc. (NYSE:MRK) Obtains FDA’s Accelerated Approval For Its PD-1 Inhibitor, Keytruda


Merck & Co., Inc. (NYSE:MRK) has finally obtained an approval of its KEYTRUDA. According to the U.S. Food and Drug Administration (FDA), the company’s anti-PD-1 therapy has met the necessary scientific requirements. Hence it can be used in the treatment of adult and pediatric patients suffering from refractory primary mediastinal large B-cell lymphoma (PMBCL).

KEYTRUDA’s approval is a great milestone for the company given that it is the second indication in a week. The first approval was for advanced cervical cancer in the second-line setting. All these approvals have the backing of tumor response rate and durability of response. The approvals were equally based on data collected from a KEYNOTE-170 trial, which involved 53 patients with relapsed or refractory PMBCL.

These label expansion approvals should drive sales of Keytruda in the future quarters

The market is very competitive. However, KEYTRUDA becomes the first anti-PD-1 therapy gain an approval for the treatment of PMBCL. The approval brings better tidings to the company including increased sales. In the first quarter of the year 2018, the sales stood at $1.5 billion, which was an increase of 12.9%.

The increase of sales has been attributed to the global launch of indications. The market looks pleasant. Thus, the sales are likely to gain stronger momentum in the future quarters and in the first-line lung cancer indication.

On the other hand, the approval of the anti-PD-1 therapy is a reliever for hundreds of patients suffering from PMBCL. According to Philippe Armand, a medical oncologist, the disease is very challenging to treat and more often than not, it affects the young adults.


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Keytruda is being studied for more than 30 types of cancer

Keytruda is the largest product in Merck’s portfolio. Encouraging results from multiple clinical studies are said to have caught the attention of physicians and investors. Currently, there are close to 700 studies going for this PD-L1 inhibitor, which involve more than 30 types of cancer.

Merck’s VP Jonathan Cheng, outlines, “This approval reinforces Merck’s commitment to helping patients diagnosed with hematologic cancers.” Meanwhile, Merck says it is seeking more collaboration with other biotech firms such as GlaxoSmithKline plc (ADR) (NYSE: GSK) and Pfizer Inc.(NYSE: PFE). The company has also confirmed having obtained priority review of its supplemental biologics license application (sBLA). The vaccine, which at present is for men and women 9 through 26 years of age was seeking approval for an expanded age indication.


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