Eli Lilly announced that the U.S. Food and Drug Administration has granted traditional approval for its BTK inhibitor Jaypirca (pirtobrutinib) in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor. The approval expands the drug’s label beyond the accelerated approval it received in December 2023, allowing Jaypirca to be used earlier in the treatment sequence and converting the indication to a full, non‑accelerated approval.
Jaypirca is the first FDA‑approved non‑covalent, reversible BTK inhibitor, a mechanism that enables it to retain activity in patients who develop resistance mutations that limit covalent inhibitors. The approval was based on the BRUIN CLL‑321 Phase 3 trial, which demonstrated a median progression‑free survival of 11.2 months for patients treated with Jaypirca versus 8.7 months for those receiving investigator‑chosen therapy. The trial’s results confirm the drug’s efficacy in the post‑covalent BTK inhibitor setting and support its broader use.
The expanded indication is expected to increase the patient population eligible for Jaypirca, potentially boosting Eli Lilly’s oncology sales. Market research firm GlobalData projects that Jaypirca will become the market leader among BTK inhibitors for CLL by 2032, capturing a significant share of the $211 billion U.S. oncology market projected for 2034. Jaypirca competes with Imbruvica, Calquence, and Brukinsa, but its non‑covalent mechanism gives it a competitive edge in patients who have progressed on covalent agents.
Executive Vice President and President of Lilly Oncology Jacob Van Naarden said, “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.” He added that the robust efficacy and safety data from the only study of its kind in the post‑covalent BTK inhibitor setting give the company confidence that the drug will serve a larger patient cohort at an earlier stage of treatment.
The approval not only strengthens Lilly’s position in the BTK inhibitor market but also signals a broader strategy to expand the use of its oncology portfolio into earlier lines of therapy. By converting an accelerated approval to a traditional one, Lilly removes the uncertainty associated with accelerated status and positions Jaypirca for broader reimbursement and market penetration. The move aligns with the company’s focus on delivering differentiated therapies that address unmet needs in hematologic malignancies and supports its long‑term growth trajectory in oncology.
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