2023-06-19 13:35:56
The drug pralsetinib can be used in the treatment of certain patients with non-small cell lung cancer (NSCLC). These are adult patients with the so-called RET fusion-positive form.
A study of safety data for pralsetinib showed that patients are more susceptible to tuberculosis. Worldwide, tuberculosis has been diagnosed in nine patients receiving treatment with this medicine. In most cases, tuberculosis did not occur in the lungs, but in the lymph nodes, abdominal cavity or kidneys, for example.
Control
The MEB recommends checking patients for active or inactive (latent) tuberculosis before starting treatment. If patients have this form of tuberculosis, treatment with an antimycobacterial agent follows before starting treatment with pralsetinib.
Healthcare providers should avoid co-administration of pralsetinib and antimycobacterial agents, such as rifabutin and rifampicin. These CYP3A4 inducers may decrease pralsetinib blood concentrations. If simultaneous administration cannot be avoided, increasing the dose of pralsetinib is an option, according to the MEB.
DHPC
Marketing authorization holder Roche has sent a Direct Health Professional Communication (DHPC) on this subject to doctors who treat a patient with pralsetinib in a ‘named patient programme’.
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