Meeting highlights from the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee held from 10 to 12 May 2023 consist of a direct healthcare professional communication (DHPC) that aims to inform healthcare professionals of the increased risk of tuberculosis and measures to minimise this risk, which was identified following a post-marketing review of pralsetinib (Gavreto).
In the EU, pralsetinib is indicated as monotherapy for the treatment of adult patients with rearranged-during-transfection (RET) fusion-positive advanced non-small cell lung cancer not previously treated with a RET inhibitor.
Tuberculosis, mostly extrapulmonary, has been reported in patients receiving this medicine. An investigation of global safety data for pralsetinib identified 9 cases of tuberculosis in patients, of which the majority (7 of 9) occurred in tuberculosis-endemic regions.
Before starting treatment, patients should be evaluated for active and inactive (latent) tuberculosis, as per local recommendations. In patients with active or latent tuberculosis, standard antimycobacterial therapy should be initiated before treatment with pralsetinib is started.
The DHPC for pralsetinib will be forwarded to EMA’s Committee for Medicinal Products for Human Use. When adopted, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registries in EU Member States.
