Reason for request

New indication

Key points

Disapproval of reimbursement of KEYTRUDA (pembrolizumab) as monotherapy for the treatment of adult patients with the following MSI-H or dMMR tumours:

  • advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
  • unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.

Therapeutic improvement?

No therapeutic improvement in the care pathway in all assessed indications.

Role in therapeutic strategy?

Not applicable.


Clinical Benefit

Insufficient

The Committee deems that the actual clinical benefit of KEYTRUDA (pembrolizumab) as monotherapy is insufficient for all of the indications.


Clinical Added Value

Not applicable

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