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 as adjuvant treatment certain patients with non-small cell lung cancer.
The Rahway, N.J., drugmaker said the recommendation covers Keytruda for adults who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
The European Commission, which generally follows the CHMP’s advice, is expected to make a decision by the end of the year, Merck said.
Lung cancer is the leading cause of cancer death around the world, with non-small cell lung cancer accounting for more than 80% of all cases.
Merck is studying Keytruda, a cancer drug that harnesses a patient’s immune system to fight tumors, in a raft of trials across a wide variety of cancers and treatment settings. The drug, which is approved in dozens of indications worldwide, generated sales of more than $12 billion in the first half of 2023.
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