Wedoany.com Report-Dec.5, Eli Lilly and Company has obtained U.S. Food and Drug Administration (FDA) approval for an expanded indication of Jaypirca® (pirtobrutinib) 50 mg and 100 mg tablets. The medicine is now approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior covalent Bruton tyrosine kinase (BTK) inhibitor.

The trial enrolled 238 patients, randomised 1:1 to receivethe therapy or an investigator-chosen regimen.

The new approval allows Jaypirca to be used immediately after prior covalent BTK inhibitor therapy and converts the previous December 2023 accelerated approval (limited to later-line treatment) into full traditional approval.

Jaypirca is the first and only FDA-approved non-covalent (reversible BTK inhibitor. It is designed to re-establish BTK inhibition in patients whose disease has progressed following treatment with covalent BTK inhibitors such as ibrutinib, acalabrutinib, or zanubrutinib.

The expanded approval is supported by data from the Phase 3 BRUIN CLL-321 trial, an open-label, randomized study that enrolled 238 adults with relapsed or refractory CLL/SLL previously treated with a covalent BTK inhibitor. Patients were assigned 1:1 to receive either Jaypirca 200 mg orally once daily or the investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab.

The primary endpoint was progression-free survival (PFS) assessed by an independent review committee according to 2018 iwCLL criteria. Key secondary endpoints included investigator-assessed PFS, overall response rate, duration of response, event-free survival, time to next treatment, overall survival, patient-reported outcomes, safety, and tolerability.

Jacob Van Naarden, executive vice-president of Lilly Oncology and president of Loxo@Lilly, commented: "This label expansion allows physicians to use Jaypirca directly after a covalent BTK inhibitor, the setting where we have always believed it has its most unique potential impact for patients.

"With robust efficacy and safety evidence from the only study of its kind in the post-covalent BTK inhibitor treatment setting, we're proud to now offer this therapy to more patients with CLL or SLL at an earlier stage of their treatment plan."

The updated prescribing information reflects these results and broadens access to Jaypirca for patients whose disease has progressed on or after prior covalent BTK inhibitor therapy.