Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2024 meeting.
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…
