FDA Gives Conditional Approval For Eli Lilly's Drug For Rare Blood Cancer

The FDA approved Eli Lilly And Co's LLY Jaypirca (pirtobrutinib) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy.
Jaypirca is the first BTK inhibitor of any kind specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor.
Also Read: FDA Rejects Eli Lilly's Donanemab For Alzheimer's Disease, Needs More Data.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-fetal toxicity.
Jaypirca was approved under the FDA's Accelerated Approval pathway based on data from a subset of patients in the BRUIN Phase 1/2 trial.
The efficacy was based on 120 patients with MCL treated with Jaypirca 200 mg once daily until disease progression or unacceptable toxicity.
The study showed an overall response rate of 50% (60 patients), with 13% achieving a complete response.
Jaypirca will be available in the U.S. in the coming weeks.
The confirmatory Phase 3 trial, BRUIN MCL-321) is currently enrolling patients.
Price Action: LLY shares were up 1.73% at $348.01 premarket on the last check Monday.

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