• The FDA approved Eli Lilly And Co's (NYSE: 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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