JAYPIRCA (pirtobrutinib) - Mantle cell lymphoma (MCL)

The clinical benefit of JAYPIRCA (pirtobrutinib) 100 mg film-coated tablets is low only as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor and ineligible for treatment with TECARTUS (brexucabtagene autoleucel).

The Committee makes maintenance of the low clinical benefit conditional on reassessment of the drug within a maximum period of 2 years, in particular based on data from the BRUIN-MCL-321 study that will be submitted to the EMA by the pharmaceutical company within the context of the conditional MA.

Considering:

• the low level of evidence provided by the phase 1/2, non-comparative BRUIN-18001 study on a limited number of patients, the results of which suggest an efficacy signal for pirtobrutinib without enabling it to be concluded that it provides a demonstrated clinical benefit compared to the available alternatives in adult patients with relapsed or refractory MCL who have been previously treated with a BTK inhibitor and ineligible for treatment with TECARTUS (brexucabtagene autoleucel);
• the absence of sufficiently robust comparative data, meaning that it is not possible to demonstrate the relative efficacy compared to that of the therapeutic alternatives or a placebo effect;
• concomitant development with TECARTUS (brexucabtagene autoleucel), with which no direct comparison was expected on the date of this assessment but for which the absence of an indirect comparison conducted by the pharmaceutical company is regrettable;
• the exploratory nature of the quality of life analyses;
• the safety profile of JAYPIRCA (pirtobrutinib), marked by serious adverse events in 38.6% of patients;
• a partially met medical need, with a benefit of having an additional alternative in relapsed or refractory patients after treatment with a BTK inhibitor and ineligible for treatment with TECARTUS (brexucabtagene autoleucel);
• and pending the results of the phase 3 study comparing pirtobrutinib with a covalent BTK inhibitor in previously treated MCL patients with no prior BTK inhibitor therapy,

the Committee deems that, based on the current data, and pending the findings of the BRUIN-MCL-321 study, JAYPIRCA (pirtobrutinib) 100 mg film-coated tablets provides no clinical added value (CAV V) in the care pathway for relapsed or refractory patients who have been previously treated with a BTK inhibitor and ineligible for treatment with TECARTUS
(brexucabtagene autoleucel).

The Committee considers that the JAYPIRCA (pirtobrutinib) development plan is likely to provide data that will enable its assessment to be updated. The results are expected before 31/12/2026 by the Committee, which will reassess this proprietary medicinal product in the light of these data in 2027.