EU committee recommends Jaypirca for certain leukemia patients
CHMP panel says treatment should be approved for CLL
A European Medicines Agency (EMA) committee recommended that Jaypirca (pirtobrutinib) be approved to treat some adult patients with chronic lymphocytic leukemia (CLL), a type of blood cancer.
The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), favors Jaypirca for people with relapsed or treatment-resistant (refractory) CLL and who previously received treatment that blocks, or inhibits, a protein called Bruton’s tyrosine kinase (BTK).
“We are pleased to receive a positive opinion from the CHMP, signaling that the European Union may lead the way in broadening patient access to Jaypirca for those with relapsed or refractory CLL in the post-BTK inhibitor setting,” Jacob Van Naarden, president of Lilly Oncology and executive vice president at Eli Lilly, the company that markets Jaypirca, said in a company press release.
The European Commission, which has final say over EU therapy approvals, will review the panel’s recommendation.
“There are currently no treatment options that have been specifically studied in [an appropriately-controlled] Phase 3 trial in this patient population, and we are hopeful Jaypirca will be a meaningful new option for patients. We look forward to the European Commission’s decision in the coming months,” Van Naarden said.
Seeking other approvals
Similar applications have been submitted to regulatory agencies around the world, including in the U.S.
Jaypirca is conditionally approved in the EU to treat adults with relapsed or refractory MCL and who have previously received a different BTK inhibitor. In the U.S., it is conditionally approved for CLL, relapsed or refractory MCL, and another blood cancer in adults who have previously received at least two lines of therapy including a BTK inhibitor, among other criteria.
Conditional, or accelerated, approval, allows promising experimental therapies to be marketed based on promising early clinical trial data, with full approval being dependent on additional trial data confirming their safety and efficacy.
BTK is a signaling protein that helps drive the growth of some types of blood cancer cells, including CLL and mantle cell lymphoma (MCL). Jaypirca is an oral therapy that works by blocking this protein in a non-covalent, or reversible, manner. Many other BTK inhibitors target the protein in a covalent, or irreversible, way.
“Jaypirca allows for continued targeting of the BTK pathway following treatment with a covalent BTK inhibitor and has the potential to be an important new option in a setting with significant unmet need,” said Paolo Ghia, MD, a professor of medical oncology at Università Vita-Salute San Raffaele in Italy.
CHMP’s recommendation was based on data from a global Phase 3 clinical trial called BRUIN CLL-321 (NCT04666038), which according to Lilly was the first CLL trial to specifically enroll patients who’d been previously treated with a BTK inhibitor.
Participants were randomly assigned to receive either Jaypirca or standard treatment, which consisted of rituximab (sold as Rituxan and biosimilars) plus either Zydelig (idelalisib) or bendamustine (sold as Treanda, among others).
Results showed that patients treated with Jaypirca lived significantly longer without disease progression than those on standard of care (14 months vs. 8.7 months), reflecting a 46% lower risk of progression or death with Jaypirca. This meant that the trial met its main goal.
Survival benefits were seen consistently across several subgroups of patients, including those previously treated with the CLL therapy venetoclax (sold as Venclyxto in Europe and Venclexta in the U.S.) and those with poor prognosis, according to Lilly.
The median time to next treatment or death, a secondary measure, was two years for Jaypirca-treated patients and less than a year for those given standard therapy, indicating a 63% lower chance of needing another therapy or dying.
The therapy’s safety profile was generally consistent with that reported for earlier trials. The most commonly reported adverse events in patients treated with Jaypirca included fatigue, diarrhea, rash, bruises, low levels of neutrophils (a type of immune cell), and anemia (low levels of red blood cells).
“Results from the BRUIN CLL-321 trial show that Jaypirca delivers clinically meaningful outcomes in a post-BTK inhibitor setting with markedly prolonged time to next treatment, including in those with high-risk characteristics often associated with poor prognosis,” Ghia said. “The CHMP opinion is an important step toward bringing Jaypirca to [CLL] patients in the European Union.”
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