EMA Panel Endorses New Indications for Two Cancer Drugs

Nick Mulcahy


October 18, 2019

The drug review panel for the European Medicines Agency (EMA) has endorsed new indications for two cancer therapies.

The Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization of pembrolizumab (Keytruda, Merck), as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumors express PD-L1 with a CPS ≥ 1.

The immunotherapy was approved for the same use in the United States by the Food and Drug Administration in June.

Pembrolizumab is currently indicated for multiple other cancer types in the European Union.

CHMP also adopted a positive opinion recommending an extension to the existing indication of daratumumab (Darzalex, Janssen-Cilag).

The monoclonal antibody is recommended for approval for use in combination with lenalidomide and dexamethasone or with bortezomib, melphalan, and prednisone for the treatment of adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Previously, use of the combination of lenalidomide and dexamethasone in this setting was not part of the daratumumab indication.

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