Merck's Crown Jewel Cancer Drug Keytruda Scores FDA Approval For Third Indication In Cervical Cancer

Friday, the FDA approved Merck & Co Inc’s MRK Keytruda (pembrolizumab) in combination with chemoradiotherapy (CRT) for FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. 

The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which Keytruda plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% compared to placebo plus CRT.

The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.

Also Read: Double Flops For Merck’s Lung Cancer Studies.

Median PFS was not reached in either group. 

This approval marks the third indication for Keytruda in cervical cancer and the 39th indication for Keytruda in the U.S.

Cervical cancer is the fourth most common cancer in women globally. In the U.S., it is estimated that there were approximately 13,960 new cases of invasive cervical cancer and about 4,310 deaths from cervical cancer in 2023.

In the U.S., Keytruda has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without Roche Holdings AG’s RHHBY Avastin (bevacizumab), for persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 and as a single agent for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1.

Reuters noted that Keytruda is set to lose certain U.S. patents toward the end of the decade and is expected to bring in nearly $25 billion in sales in 2023.

Price Action: MRK shares are up 0.01% at $118.64 on the last check Tuesday.