Lily's 'Jaypirca' launches in KOR

First and only reversible BTK inhibitor

A new treatment option for patients with MCL whose disease has progressed after previous therapies

Reimbursement criteria for Jaypirca have been estabilshed by the the CDRC of HIRA in December 2024

Product photo of Jaypirca

Lily Korea announced on January 2 that Jaypirca (ingredient name: pirtobrutinib), a treatment for mantle cell lymphoma (MCL), was launched in South Korea on December 26.

 

To date, Jaypirca is the first reversible Bruton's tyrosine kinase (BTK) inhibitor of any kind.

 

Jaypirca was approved by the Ministry of Food and Drug Saftey (MFDS) in August 2024 for its efficacy and effects as a 'monotherapy for adult patients with relapsed or refractory MCL previously received at least two treatments.' Before the approval of Jaypirca, there was no drug approved in South Korea for patients with relapsed or refractory MCL whose symptoms advanced after previously receiving a BTK inhibitor.

 

Jaypirca is the first reversible BTK inhibitor to demonstrate clinical significance in patients with relapsed or refractory MCL who have undergone one or more BTK treatments.

 

It selectively inhibits BTK with a 300-fold greater selectivity than any other kinases (98%) in a preclinical study.

 

The basis for approval was the BRUIN Phase 1/2 clinical trials, which evaluated the effectiveness and safety of Jaypirca in patients with relapsed or refractory MCL who had previously received one or more BTK inhibitors.

 

The primary analysis set (PAS), involving 90 patients who had previously been treated with one or more BTK inhibitors, had an overall response rate (ORR) of 56.7% and a duration of response (DoR) of 17.6 months.

 

The most common adverse reactions after the Jaypirca treatment were fatigue (26.3%), decreased neutrophil count (22.8%), diarrhea (22.1%), and bruising (21%).

 

The rate of discontinued treatment due to adverse reactions was 1.2%.

 

The rate of reduced volume of treatment due to adverse reactions was 3.3%.

 

Previously, Jaypirca was approved under the FDA's Accelerated Approval in January 2024 based on the response rate results.

 

In South Korea, in June 2024, it was designated an orphan drug as the monotherapy for patients with relapsed or refractory MCL previously treated with BTK inhibitors.

 

Last month, Jaypirca was the only drug considered for the reimbursement review by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) to receive a reimbursement criteria decision.

 

The remaining steps are the Drug Reimbursement Evaluation Committee (DREC) review, drug price negotiations with the National Health Insurance Service (NHIS), and a review from the Health Insurance Policy Review Committee.

 

"The launch of Jaypirca is expected to expand the treatment opportunity for patients with MCL who couldn't continue treatment because there has been no alternative medication after the disease progressed after previous therapies," Mira Kyon, Head of Lily Korea Oncology Division, stated.

 

"Lily will continue to put efforts into providing better patient treatment opportunities and suggesting new paradigms to blood cancer therapies."