MRK Merck and Co Inc

   By Colin Kellaher 
 

Merck & Co. (MRK) on Wednesday said the U.S. Food and Drug Administration granted priority review to Merck's supplemental biologics license application for Keytruda in advanced small cell lung cancer, or SCLC.

The Kenilworth, N.J., drug maker said the sBLA seeks accelerated approval of the cancer drug as monotherapy for SCLC patients whose disease has progressed after two or more lines of prior therapy.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from 10 months. SCLC has a five-year overall survival rate of 6%, Merck said, adding that the FDA set a target action date of June 17.

Keytruda, a cancer drug that harnesses a patient's immune systems to fight tumors, is marketed to treat lung, skin, bladder and other cancers.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 20, 2019 07:51 ET (12:51 GMT)

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