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

Friday, the FDA approved Eli Lilly and Co's LLY Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy. 

Jaypirca was approved under the FDA's Accelerated Approval pathway based on the overall response rate (ORR) and duration of response (DOR) from the Phase 1/2 BRUIN trial. The trial showed an overall response rate of 72%.

The efficacy assessment was based on 108 patients with CLL/SLL treated with Jaypirca who were previously treated with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Jaypirca 200 mg was given once daily and was continued until disease progression or unacceptable toxicity.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor. The company says that Jaypirca has been shown to extend the benefit of BTK inhibition.

The labeling for Jaypirca contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity. 

This is the second FDA-approved indication for Jaypirca following the January 2023 Accelerated Approval for adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy.

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Price Action: LLY shares closed at $583.85 on Friday.