2023-06-16 11:04:46
News item | 6/16/2023 | 11:00 am
Tuberculosis sometimes occurs in patients with a specific form of lung cancer who receive the drug Gavreto (pralsetinib). The Medicines Evaluation Board (MEB) advises doctors to test patients for tuberculosis before starting treatment.
Pralsetinib, the active substance of Gavreto, is a medicine that can be used in the treatment of certain patients with non-small cell lung cancer (NSCLC). This concerns 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. Tuberculosis was diagnosed worldwide in 9 patients receiving pralsetinib treatment. In most cases, tuberculosis did not occur in the lungs, but in the lymph nodes, abdominal cavity or kidneys, for example.
Advice to healthcare providers
- Before starting treatment, check patients for active or inactive (latent) tuberculosis.
- Treat patients who have an active or latent form of tuberculosis with an antimycobacterial agent (an agent against the bacteria that causes tuberculosis) before starting treatment with pralsetinib.
- Avoid co-administration of pralsetinib and antimycobacterial agents such as rifabutin and rifampicin. These CYP3A4 inducers may decrease pralsetinib blood concentrations. If co-administration cannot be avoided, increase pralsetinib dose.
The risk of tuberculosis and the recommendation to test patients before starting treatment is also included in the Gavreto (pralsetinib) product information and package insert.
Risk information letter
The marketing authorization holder Roche has sent a letter on this subject, a so-called Direct Healthcare Professional Communication (DHPC). The letter containing this important risk information was sent in consultation with the MEB and the Healthcare and Youth Inspectorate (IGJ) to doctors who treat a patient with pralsetinib in a ‘Named Patient Program‘ (delivery on doctor’s note).
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