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Merck's Keytruda gets two additional FDA approvals

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Merck’s best-selling immuno-therapy drug, Keytruda, received two new approvals from the FDA
Merck’s best-selling immuno-therapy drug, Keytruda, received two new approvals from the FDA - ()

Keytruda, Merck & Co.’s best-selling drug, was granted accelerated approval by the U.S. Food and Drug Administration to treat patients with B-Cell Lymphoma, a rare type of blood cancer, and cervical cancer.

“The approvals were based on tumor response rate and durability of response,” according to a statement released by the FDA. “Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

In May 2017, the FDA granted accelerated approval of Keytruda for patients whose cancers have a specific genetic features. It was the first time the agency had granted approval for an immunotherapy drug, and helped cement immuno-oncology as the wave of the future for cancer treatment.

The drug was originally administered to newly diagnosed lung cancer patients who, when receiving Keytruda in combination with other standard cancer drugs, lived significantly longer than patients receiving the same therapies without Keytruda.

In April, Kenilworth-based Merck announced sales of Keytruda had topped $1.46 billion in the first quarter to become its best-selling drug.

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Vince Calio

Vince Calio


Vince Calio covers health care and manufacturing for NJBIZ. You can contact him at vcalio@njbiz.com.

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