Keytruda, Merck & Co., Inc. (NYSE: MRK)'s flagship cancer immunotherapy, has secured FDA clearance for two more indications, cementing its positioning as the top oncology drug and expanding its lead over Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo.
Kenilworth, New-Jersey-based Merck said the FDA has greenlighted Keytruda, an anti-PD-1 therapy, for two indications:
A monotherapy in patients whose tumors express PD-L1 for first-line treatment of patients with metastatic, or with unresectable, recurrent head and neck squamous cell carcinoma, or HNSCC.
Combo therapy along with platinum and fluorouracil, a commonly used chemotherapy, for patients with metastatic or unresectable recurrent HNSCC.
The approval was granted based on positive results from the pivotal Phase 3 KEYNOTE-048 trial, Merck said.
Why It's Important
Merck's Keytruda is now the first anti-PD-1 therapy for treating head and neck cancer.
"Metastatic or recurrent head and neck cancer has been an area of significant unmet need, so it is encouraging to have immunotherapy regimens available for patients in the first-line setting," Barbara Burtness of the Yale Cancer Center's development therapeutics research program said in a statement.
Incidentally, Keytruda received approval as a treatment option for recurrent or metastatic HNSCC with disease progression, on or after platinum-containing chemotherapy, in 2016.
Merck is awaiting approval of Keytruda as a third-line treatment of advanced small cell lung cancer, with the PDUFA date scheduled for June 17.
The stock was advancing by 0.64 percent to $83.01 in premarket trading Tuesday.
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Photo courtesy of Merck.
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