Merck Gets CHMP Backing for Expanded Keytruda Use in Melanoma

By Colin Kellaher

Merck & Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its blockbuster cancer drug Keytruda for certain patients with melanoma, the most serious form of skin cancer.

The Kenilworth, N.J., drugmaker said the recommendation covers Keytruda as monotherapy for the adjuvant treatment of patients 12 year of age and older with stage IIB or IIC melanoma and who have undergone complete resection.

Merck said the CHMP also recommended expanding the indications for Keytruda in advanced melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients ages 12 and up.

The company said Keytruda, if approved, would be the first anti-PD-1 immunotherapy treatment option for patients 12 and older in the EU across stage IIB, IIC and III melanoma following complete resection.

The European Commission, which generally follows the CHMP's advice, is expected to make a decision during the third quarter, Merck said.

Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in dozens of indications around the world. Sales of the drug topped $17 billion last year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

May 20, 2022 08:56 ET (12:56 GMT)

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