4 NEW DRUGS NEAR APPROVAL IN EUROPE

Four new cancer drugs have been recommended for approval in the European Union (EU).

They include two new agents for metastatic melanoma — encorafenib (Braftovi, Pierre Fabre) and binimetinib (Mektovi, Pierre Fabre); an immunotherapy for use in non–small cell lung cancer — durvalumab (Imfinzi, AstraZeneca); and a cyclin-dependent kinase (CDK4/6) inhibitor for use in metastatic breast breast cancer — abemaciclib (Verzenios, Eli Lilly).

The drugs were recommended for approval at the July meeting of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

In addition to the new drugs, the committee also gave a positive opinion for two biosimilar products for use in cancer patients — Pelgraz (Accord Healthcare) and Udenyca (ERA Consulting GmbH). Both are biosimilars of the granulocyte colony-stimulating factor pegfilgrastim, and both are intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

At the same meeting, the CHMP also recommended granting a marketing authorization for two generic medicines for use in cancer patients — Gefitinib Mylan(gefitinib), for the treatment of non–small cell lung cancer, and Lenalidomide Accord (lenalidomide), for the treatment of multiple myeloma.