Merck Gets CHMP Backing for Expanded Keytruda Use in Melanoma
20 Mai 2022 - 03:11PM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 20, 2022 08:56 ET (12:56 GMT)
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