EMA Recommends Blenrep, Adakveo, and Equidacent for Approval; Recommends Change in Prescription Status for Crysvita and Imfinzi

During the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) meeting this July, the CHMP recommended the approval of two biologics and one biosimilar:

  • GlaxoSmithKline’s Blenrep (belantamab mafodotin), for treatment of relapsed and refractory multiple myeloma
  • Novartis’ Adakveo (crizanlizumab), for prevention of vaso-occlusive crises in patients with sickle cell disease
  • Centus Biotherapeutics’ Equidacent (bevacizumab), for treatment of colon or rectum carcinoma; breast cancer; non-small cell lung cancer; renal cell cancer; epithelial ovarian, fallopian tube, or peritoneal cancer; and cervical carcinoma

The CHMP adopted a positive opinion for Equidacent (bevacizumab), and recommended granting a marketing authorization for Adakveo (crizanlizumab).  A conditional marketing authorization was recommended for Blenrep (belantamab mafodotin).

In addition, the CHMP recommended a change in classification status from prescription to nonprescription for Ultragenyx Pharmaceutical’s Crysvita (burosumab) and AstraZeneca’s Imfinzi (durvalumab).

The CHMP also recommended that marketing authorizations be refused for Stemline Therapeutics’ Elzonris (tagraxofusp) and Swedish Orphan Biovitrum’s Gamifant (emapalumab), noting that the small study size and the study designs for the medications made it not possible to determine their effectiveness.