The approval comes nearly a year after Jaypirca gained its first indication in January 2023, when the FDA approved its use to treat adults with relapsed or refractory mobile mantle lymphoma. Jaypirca is the first, and still only, FDA-approved reversible BTK inhibitor on the market, according to Lilly’s press release on Friday.
In the release, William Wierda, professor at the University of Texas MD Anderson Cancer Center, called Jaypirca a “new treatment option” for chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) patients, for whom there are few alternatives after disease progression following treatment with covalent BTK inhibitors or BCL-2 inhibitors.
Jaypirca is a small molecule inhibitor of the enzyme BTK, which, in general circumstances, serves for the development, proliferation and function of B lymphocytes. BTK is a well-validated target in several leukemias and lymphomas.
BTK blockers such as J’s Imbruvica (ibrutinib)
Jaypirca, on the other hand, establishes non-covalent bonds with BTK, preventing the progression of resistance. In addition, because Jaypirca depends on the presence of amino acid residues expressed at the active site of the enzyme, it can exert its effects on both wild-type BTK and mutated BTK.
The most recent approval of Jaypirca is supported by knowledge of a subset of patients in the Phase I/II BRUIN study. In 108 patients with CLL or SLL, a Jaypirca dose of two hundred mg once daily resulted in an objective reaction rate of 72%. with an average reaction time of 3. 7 months. Response to treatment, as decided by an independent review committee, lasted an average of 12. 2 months.
As for safety, 56% of patients treated with Jaypirca experienced serious side effects, the most common of which were pneumonia, COVID-19, sepsis and febrile neutropenia. Adverse events led to treatment interruptions in 42% of treated patients, and to dose reductions in 3.6%. Nine percent of patients permanently discontinued Jaypirca treatment due to toxicities.
As part of its obligations under the FDA’s fast-track procedure and to keep Jaypirca on the market, Lilly is developing the Phase III BRUIN CLL-321Array, an open-label, randomized Phase III array that will serve as a confirmatory test for Jaypirca. Jaypirca objected to idelalisib or bentamustine plus rituximab in CLL or SLL.
Lilly has shared key knowledge of BRUIN CLL-321 with the FDA and promises to make it available to the wider medical network at an upcoming congress.
Tristan Manalac is an independent scientist based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac. com or tristan. manalac@biospace. com.
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