EU panel backs extending Jaypirca use to more leukemia patients
New authorization would cover all adults with CLL in region
Written by |
A European Medicines Agency (EMA) committee is recommending expanded approval for Jaypirca (pirtobrutinib), an oral therapy used to treat chronic lymphocytic leukemia (CLL), a type of blood cancer.
Jaypirca was approved last year in the European Union to treat CLL in adults whose cancer was relapsed or refractory (meaning the cancer had failed to respond or had come back after prior treatments) and who had previously been treated with a Bruton’s tyrosine kinase (BTK) inhibitor. That approval followed a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP), a regulatory body tasked with reviewing data on experimental medicines under consideration for approval.
The CHMP now recommends that Jaypirca’s approval be expanded to treat CLL across all lines of therapy and regardless of prior BTK inhibitor treatment. The committee’s opinion will be reviewed by the European Commission, which has final say over medication approvals in the EU. The commission doesn’t have to abide by the CHMP’s recommendations, but it almost always does. A final decision is expected in the next month or two, according to Jaypirca’s maker Eli Lilly.
“Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important,” Jacob Van Naarden, executive vice president and president of Lilly Oncology, said in a company press release. “This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy.”
CLL is caused by the abnormal growth of certain immune cells. Jaypirca works by blocking BTK, an enzyme that helps drive the growth of these cancerous immune cells. In addition to CLL, the therapy is approved in the EU for certain adults with mantle cell lymphoma, another form of blood cancer. It’s also approved in the U.S. for some adults with these blood cancers.
Trial data point to promising results
The CHMP’s new opinion was based on data from two Phase 3 clinical trials: BRUIN CLL-313 (NCT05023980) and BRUIN CLL-314 (NCT05254743). Both studies enrolled people with CLL or a related blood cancer, small lymphocytic lymphoma (SLL).
The BRUIN CLL-313 study enrolled nearly 300 CLL/SLL patients who had not been previously treated and whose cancer did not harbor a specific genetic mutation, 17p deletion. Participants were randomly assigned to receive either Jaypirca or a combination of two approved CLL treatments: the chemotherapy bendamustine (sold as Bendeka and Treanda, among others) and the immunotherapy rituximab (sold as Rituxan, among others). Results showed that Jaypirca reduced the risk of disease progression or death by 80% compared with these older therapies.
The BRUIN CLL-314 trial, meanwhile, enrolled more than 600 people with CLL/SLL who had not received a BTK inhibitor, regardless of prior treatment. Participants were randomly assigned to treatment with Jaypirca or with an older approved BTK inhibitor called Imbruvica (ibrutinib), which is made by Pharmacyclics (an Abbvie company) and Janssen Biotech. Results showed Jaypirca was at least as effective as Imbruvica at triggering a treatment response, meaning the cancer burden decreased.
“Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor,” Van Naarden said.
The most common side effects of Jaypirca include reduced counts of immune and other blood cells, fatigue, and decreased calcium levels.
“Results from BRUIN CLL-313 and BRUIN CLL-314 provide compelling evidence that [Jaypirca] can make a meaningful difference for people living with CLL across multiple lines of therapy,” said Paolo Ghia, MD, a professor of medical oncology at Università Vita-Salute San Raffaele in Italy. “The strong efficacy and tolerability demonstrated in these trials underscores the clinical value [Jaypirca] may offer patients.”
Ghia said the CHMP’s new opinion “is an exciting and significant milestone, bringing us closer to a future where [Jaypirca] is an option for more people with CLL across the European Union.”
mariaanaluizacam
Não é a primeira vez que visito este web site, gosto muito dos seus textos, são agradáveis de se ler. Tenho visto todos os dias. E é realmente muito bom! Parabéns!