New drug approvals recommended by European Medicines Agency

Roche’s Phesgo (pertuzumab/trastuzumab) is one of the half dozen medicines that the European Medicines Agency’s human medicines committee (CHMP) has recommended for approval at its November 2020 meeting. Phesgo has been endorsed as a treatment for early and metastatic breast cancer. Administered as a subcutaneous, fixed-dose combination of pertuzumab and trastuzumab, Phesgo offers patients a less invasive and faster administration procedure, compared to the current administration of intravenous pertuzumab and subcutaneous trastuzumab formulations. Roche’s Xofluza (baloxavir marboxil) also received recommendation for approval for the treatment and post-exposure prophylaxis of uncomplicated influenza.

Roclanda (latanoprost/netarsudil) of Aerie Pharmaceuticals Ireland was endorsed for the reduction of elevated intraocular pressure in adults with primary open-angle glaucoma or ocular hypertension, where monotherapy with a prostaglandin or netarsudil does not provide adequate intraocular pressure reduction.

Onbevzi (bevacizumab), Samsung Bioepis’ biosimilar, received CHMP’s endorsement for approval for the treatment of breast cancer, non-small cell lung cancer, renal cell cancer, carcinoma of the colon or rectum, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. Onbevzi was observed to have comparable quality, safety, and efficacy as Avastin (bevacizumab), which was authorized 15 years ago.

Stemline Therapeutics’ Elzonris (tagraxofusp) received recommendation for approving marketing authorization for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive type of acute myeloid leukaemia. The drug had been refused approval in July 2020, but after re-examination, CHMP recommended approval under exceptional circumstances, but for a restricted indication for first-line treatment

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