Yes, Jaypirca (pirtobrutinib) is FDA-approved for relapsed or refractory mantle cell lymphoma (MCL) after at least two prior therapies, including a BTK inhibitor.[1]
How was Jaypirca approved for MCL?
The FDA granted accelerated approval in January 2023 based on the Phase 1/2 BRUIN trial, where 52% of 134 MCL patients achieved an objective response (24% complete response), with median response duration of 8.3 months.[1][2] Full approval depends on confirmatory trials.
Who qualifies for Jaypirca in MCL?
It's for adults with MCL that has progressed after a Bruton tyrosine kinase (BTK) inhibitor like Imbruvica (ibrutinib) and one other systemic therapy. It targets patients whose cancer resists covalent BTK inhibitors.[1]
How does Jaypirca work for MCL?
Jaypirca is a non-covalent BTK inhibitor that binds reversibly to BTK, blocking B-cell signaling in lymphomas like MCL. This differs from covalent inhibitors, allowing use after resistance develops.[2]
What are common side effects in MCL patients?
Fatigue (41%), diarrhea (36%), bruising (35%), rash (30%), and edema (25%) occur most often. Serious risks include infections, bleeding, and second primary cancers; monitor blood counts.[1][2]
How does Jaypirca compare to other MCL treatments?
Unlike Imbruvica or Calquence (which lose efficacy after resistance), Jaypirca works post-BTK failure. Vs. CAR-T like Brexucabtagene autoleucel, it's oral and less invasive but for later lines.[2]
When did Jaypirca's patent for MCL expire?
Jaypirca's key composition-of-matter patent (US 9,725,458) expires in 2036, with MCL-specific method claims extending protection; generics unlikely before then.3
[1]: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-pirtobrutinib-mantle-cell-lymphoma
[2]: https://www.jaypirca.com/mcl