Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020

Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its November 2020 meeting.

The Committee recommended granting a marketing authorisation for Phesgo (pertuzumab / trastuzumab) for the treatment of early and metastatic breast cancer.

The CHMP adopted a positive opinion for Roclanda (latanoprost / netarsudil) for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.

Xofluza (baloxavir marboxil) received a positive opinion from the CHMP for the treatment and post-exposure prophylaxis of uncomplicated influenza.

The biosimilar medicine Onbevzi (bevacizumab) received a positive opinion for the treatment of 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.

Positive recommendation on a new medicine following re-examination

The CHMP recommended approving the marketing authorisation for Elzonris* (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive type of acute myeloid leukaemia (blood cancer). The Committee had initially refused the application in July 2020 for Elzonris to be used for the treatment of BPDCN regardless of whether patients had been previously treated with other medicines or not. After re-examination, the CHMP recommended that marketing authorisation 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).

Negative recommendation on a new medicine following re-examination

The applicant for Gamifant (emapalumab) requested a re-examination of the Committee's negative opinion adopted at the July 2020 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine, which was intended for the treatment of primary haemophagocytic lymphohistiocytosis (a genetic disease characterised by an overactive immune system) in children under 18 years of age.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Kyprolis, Pradaxa, Tivicay, Trimbow, Xarelto and Xyrem.

13/11/2020

https://www.ema.europa.eu/en/

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