Red Hand Letter on the risk of tuberculosis with the drug pralsetinib

The Federal Institute for Drugs and Medical Devices (BfArM), together with the European Medicines Agency (EMA) and Roche, has issued a Red-Hand Letter on the risk of tuberculosis with the drug pralsetinib (Gavreto®). The drug is a so-called RET inhibitor that can be used to treat non-small cell lung cancer with a mutation in the RET gene. It is now recommended that patients be tested for tuberculosis or latent tuberculous infection before starting this specific tumor therapy and, if the results are positive, to undergo appropriate anti-tuberculous or preventive therapy. Attention must be paid to possible interactions. The product information will be revised in this regard.

Further information on the Red Hand Letter can be found here:

https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RHB/2023/rhb-gavreto.html

https://www.akdae.de/service/newsletter/newsletter-archiv/akdae-news/newsdetail/rote-hand-brief-zu-gavretor-pralsetinib-erhoehtes-risiko-fuer-tuberkulose-und-massnahmen-zur-risikominimierung

If you have any questions or require advice, please contact us at info@dzk-tuberkulose.de or 030 814 909 22.