Jaypirca (pirtobrutinib)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pirtobrutinib
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Lymphoma, Mantle-Cell
- CHMP opinion
- Wed 26 Apr 2023
- EU approval
- Mon 30 Oct 2023
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005863
- ATC
- L01
- Official record
- www.ema.europa.eu
Indication
Jaypirca as monotherapy is indicated 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. Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.