Committee for Medicinal Products for Human Use (CHMP) Meeting 12-15 September 2022 - highlights

EMA’s human medicines committee (CHMP) recommended 12 new medicines for approval and 11 extensions of therapeutic indication at its September 2022 meeting, including the following of interest:

- Zynlonta (loncastuximab tesirine) by ADC Therapeutics (NL) B.V.: this medicine is intended for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma, two types of cancer that begin in the lymphatic system when abnormal white blood cells grow. 

- extensions of indication for medicines that are already authorised in the EU: Adtralza , Biktarvy, Brukinsa (zanubrutinib), Evusheld , Exparel liposomal, Revolade, Skyrizi, Vaxneuvance (pneumococcal polysaccharide conjugate vaccine - adsorbed), Veklury (includes two extensions of indication for two paediatric populations), Xalkori (crizotinib) and Yescarta.

Withdrawals of initial applications

The application for marketing authorisation for Exkivity (mobocertinib) was withdrawn by the respective applicant. This medicine was indicated for the treatment of a certain type of lung cancer. A question-and-answer document on the withdrawal is available at the EMA link.