Eli Lilly (NYSE:LLY) has announced the FDA’s expanded approval for its BTK inhibitor drug, Jaypirca (pirtobrutinib), specifically in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indications. Jaypirca is now approved in the United States under the accelerated pathway for the treatment of adults with CLL/SLL who have undergone at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
This approval is based on data from a subset of patients in the phase I/II BRUIN study, which assessed Jaypirca in patients with hematologic malignancies, including CLL/SLL and mantle cell lymphoma (MCL). Results from the study demonstrated that patients treated with Jaypirca achieved an overall response rate of 72%, with a median duration of response of 12.2 months.
According to Lilly, Jaypirca utilizes a unique binding mechanism and boasts the most extensive body of evidence among targeted therapies for patients previously treated with an approved BTK inhibitor, such as AbbVie (ABBV) /J&J’s (JNJ) Imbruvica, AstraZeneca’s (AZN) Calquence, or BeiGene’s Brukinsa.
With this label expansion, Jaypirca becomes the first and only non-covalent (reversible) BTK inhibitor shown to extend the benefits of targeting the BTK pathway in patients previously treated with a covalent BTK inhibitor. The BRUIN study enrolled patients treated with Imbruvica, Calquence, or Brukinsa.
Earlier this year, Jaypirca received accelerated approval from the FDA to treat adult patients with relapsed or refractory (r/r) MCL after at least two lines of systemic therapy (including a BTK inhibitor), supported by data from the BRUIN study.
Eli Lilly’s shares have surged by 59.6% year-to-date compared to the industry’s 4.8% growth.
The pharmaceutical company is actively evaluating Jaypirca in two ongoing phase III studies – BRUIN CLL-321 and BRUIN MCL-321 – which will serve as confirmatory studies to support full approval for the drug in CLL/SLL and MCL indications. Despite formal review pending for the BRUIN CLL-321 study, management claims that it has achieved its primary endpoint.
Additionally, Lilly is exploring Jaypirca in late-stage studies as monotherapy and in combination with rituximab and AbbVie/Roche’s Venclexta to treat r/r CLL. The CLL/SLL space is currently competitive, with three covalent options – Imbruvica, Calquence, and Brukinsa – vying for market share, leading to a decline in Imbruvica sales in recent quarters. CLL and SLL represent slow-growing non-Hodgkin lymphomas with the primary distinction being the location of cancer cells – in the blood for CLL and the lymph nodes for SLL.
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