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CHMP recommends new Keytruda dosing schedule

Will apply to eight indications across five tumour types


MSD’s star oncology player Keytruda could be on track to a more flexible dosing schedule after it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

If approved by the EMA, the PD-1 inhibitor’s dosing schedule could span over six weeks at 400mg, instead of the current requirement of 200mg at every three weeks, allowing for a more patient-friendly regimen.

It will be applied across all eight of Keytruda’s monotherapy indications in five tumour types, including non-small cell lung cancer (NSCLC), melanoma, bladder cancer, head and neck cancer and classical Hodgkin lymphoma.

“Merck remains committed to improving the lives of people living with cancer, which includes the pursuit of innovative options for administering Keytruda to address the unique needs of patients and healthcare providers,” said Dr Scot Ebbinghaus (pictured below), vice president, clinical research, Merck Research Laboratories.


“Importantly, the positive CHMP opinion supports the approval of a six-week dosing option across all eight approved Keytruda monotherapy indications in Europe, spanning five cancer types.

“If approved by the European Commission, the Keytruda 400 mg every six weeks dose will provide both physicians and patients with greater flexibility in their treatment plans.”

A decision is expected from the EMA during the second quarter of 2019, and the decision could put even more pressure on its main rival Opdivo, Bristol-Myers Squibb’s PD-1 inhibitor that brought in a respectable $6.7bn year, but trailed behind Keytruda and its full year earnings of $7.2bn.

The PD-1/PD-L1 class is a crowded one and Keytruda’s dominance hasn’t scared off new players from entering the field.

Newcomer Libtayo from Sanofi and Regeneron recently received an FDA approval for use in metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

It made history by becoming the first FDA-approved drug specifically for advanced CSCC, a type of skin cancer.

Other PD-1/PD-L1 inhibitors approved for use are AstraZeneca’s Imfinzi, Pifzer and Merck’s Bavencio and Roche’s Tecentriq, and the latter is currently being explored in a variety of double and triple combinations.

It most recently gained the first immuno-oncology approval in triple negative breast cancer, claiming an advantage over Keytruda, which has phase 3 results in this indication due later this year.

Article by
Gemma Jones

15th March 2019

From: Regulatory



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