Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
Eight new medicines recommended for approval.
In particular of interest:
The committee recommended granting a conditional marketing authorisation for Augtyro (repotrectinib), a medicine intended for the treatment of adults and adolescents with advanced solid tumours, and adults with locally advanced or metastatic non-small cell lung cancer.
The CHMP recommended granting a marketing authorisation under exceptional circumstances for Gohibic (vilobelimab), for the treatment of adult patients with SARS‑CoV2‑induced acute respiratory distress syndrome who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation. EMA’s Emergency Task force was consulted during the assessment of this medicine.
Lazcluze (lazertinib) received a positive opinion for the first-line treatment of adult patients with advanced non-small cell lung cancer in combination with amivantamab.
Recommendations on extensions of therapeutic indication for 11 medicines
The committee recommended extensions of indication for 11 medicines that are already authorised in the EU: CellCept, Evkeeza, Jakavi, Kevzara, Keytruda, Opdivo, Palforzia, Rybrevant, Sarclisa, Tagrisso and Yervoy.
Withdrawal of applications
of interest:
An application to extend the therapeutic indication of Inaqovi (cedazuridine/decitabine) was also withdrawn. It concerned the use in the treatment of acute myeloid leukaemia, to include myelodysplastic syndromes, conditions where the bone marrow does not make enough healthy blood cells or platelets, and chronic myelomonocytic leukaemia, another type of cancer of the white blood cells.