EMA Recommends Breast Cancer Treatment and Four Other Medicines for Approval

The European Medicines Agency announced on Nov. 13, 2020 that its human medicines committee (CHMP) recommended five medicines for approval during its November 2020 meeting. The approvals range from drugs to treat a variety of cancers and influenza.

Among the drugs recommended is the biosimilar, Onbevzi (bevacizumab), which treats carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Marketing authorization was also recommended for Phesgo (pertuzumab/trastuzumab) for the treatment of early and metastatic breast cancer; Roclanda (latanoprost/netarsudil), which reduces elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension; and Xofluza (baloxavir marboxil) for the treatment and post-exposure prophylaxis of uncomplicated influenza.

The committee also recommended marketing authorization for Elzonris (tagraxofusp) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), after initially refusing the application in July 2020. After reexamination, “CHMP recommended that marketing authorization under exceptional circumstances could be granted but for a restricted indication in patients who had not yet received any treatment for BPDCN (first-line treatment),” according to a press release.

Source: EMA