Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Pralsetinib: Measures to Minimise Increased Risk for Tuberculosis

Before starting treatment with pralsetinib, patients should be evaluated for active and latent tuberculosis
25 May 2023
Targeted Therapy;  Cancer Treatment in Patients with Comorbidities
Non-Small Cell Lung Cancer

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.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.