EMA raccomanda l'autorizzazione all'immissione in commercio condizionata per pirtobrutinib destinato al trattamento del linfoma a cellule del mantello (MCL) recidivato o refrattario.
On 26 April 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product pirtobrutinib (Jaypirca), intended for the treatment of relapsed or refractory mantle cell lymphoma (MCL).
The applicant for this medicinal product is Eli Lilly Nederland B.V.
Jaypirca will be available as 50 mg and 100 mg film-coated tablets. The active substance of Jaypirca is pirtobrutinib, a protein kinase inhibitor. Pirtobrutinib is a reversible, non-covalent inhibitor of Bruton’s tyrosine kinase (BTK), which is involved in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
The benefit of Jaypirca is its ability to bring about a response in patients with relapsed and refractory MCL.
The most common side effects are fatigue, neutropenia, diarrhoea and contusion.
The full indication is:
- Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory MCL who have been previously treated with a BTK inhibitor.
Jaypirca should be prescribed by physicians experienced in the treatment of MCL.
This product was designated as an orphan medicine during its development.