Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor, based on the results from Phase 1/2 BRUIN clinical trial

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Lilly Corporate Centre in Indianapolis, Indiana. (Credit: Momoneymoproblemz/Wikipedia)

Loxo@Lilly, the oncology unit of Eli Lilly and Company (Lilly), has received the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat a type of mantle cell lymphoma (MCL).

Jaypirca is a highly selective, non-covalent (reversible) inhibitor of the enzyme BTK and works through a novel binding mechanism.

It works to re-establish BTK inhibition in MCL patients previously treated with a covalent BTK inhibitor, including ibrutinib, acalabrutinib, or zanubrutinib.

Jaypirca is indicated for the treatment of relapsed or refractory MCL in adults, who had at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

The drug was approved under the FDA’s Accelerated Approval pathway and continued approval for this indication is based on clinical benefit in a confirmatory trial.

It comes with a labelled warning for infections, haemorrhage, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-foetal toxicity.

Jaypirca is the first and only non-covalent (reversible) BTK inhibitor to receive US FDA approval, said Lilly.

Loxo@Lilly chief executive officer Jacob Van Naarden said: “We are pleased to bring a meaningful new therapeutic option to patients with MCL that can re-establish the benefit of targeting the BTK pathway after receiving multiple prior therapies, including a covalent BTK inhibitor.

“We are grateful to the patients, investigators, and other members of the clinical care teams for their contributions.

“Our team has been committed to rapidly advancing the development of Jaypirca for patients with MCL, and we look forward to building on this milestone by continuing to bring forward important new treatments for people with hematologic malignancies.”

The FDA approval is based on the response rate from a subset of patients in the open-label, single-arm, global, Phase 1/2 study, dubbed the BRUIN trial.

It is an ongoing first-in-human, multi-centre study of Jaypirca in patients with hematologic malignancies, including MCL.

In the study, 583 patients with hematologic malignancies were treated using Jaypirca 200mg once daily and the efficacy of the drug was assessed in 120 patients with MCL.

The study excluded patients with active central nervous system lymphoma or allogeneic hematopoietic stem cell transplantation or CAR T-cell therapy within 60 days.

In the study, 83% of patients taking Jaypirca discontinued their last BTK inhibitor due to refractory or progressive disease.

An independent review committee (IRC) assessed the efficacy based on the overall response rate (ORR) and duration of response (DOR) using the 2014 Lugano criteria.

The US drugmaker is planning to commercialise the drug in the country within a few weeks.