Lilly’s BTK inhibitor Jaypirca wins FDA approval for first-line treatment

Eli Lilly’s blood cancer treatment Jaypirca has been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

According to Fierce Pharma on the 2nd (local time), the FDA approved Jaypirca for first-line treatment, making it the first noncovalent (nonirreversible) BTK inhibitor to receive this indication.

Jaypirca was first approved in 2023 as a third-line treatment for CLL/SLL and later gained a second-line indication. With this approval, it becomes the fourth BTK inhibitor available to patients who have not previously received treatment.

In a statement, Jacob Van Naarden, president of Lilly Oncology, said, “This milestone demonstrates Jaypirca’s broad potential for use, from first-line treatment through relapsed or refractory disease.”

The first-line indication excludes patients whose tumors have a 17p deletion. This criterion matches the population enrolled in the phase 3 BRUIN CLL-313 trial, which supported the approval.

In BRUIN CLL-313, Jaypirca reduced the risk of disease progression or death by 80% compared with bendamustine plus rituximab (BR). Median progression-free survival was 33.5 months in the BR group, while it had not been reached in the Jaypirca group at the time of analysis.

In a Fierce Pharma interview last December, Van Naarden said that despite positive first-line data, Jaypirca’s primary use “is still in second-line treatment.”

Jaypirca is the only noncovalent, reversible BTK inhibitor. Because it offers a new option for patients who have received covalent BTK inhibitors, clinicians are expected to reserve it as a treatment option for patients whose disease has relapsed.

National Comprehensive Cancer Network (NCCN) guidelines also classify Jaypirca as a preferred first-line option for patients who have used a covalent BTK inhibitor, and as a category 2A option for older patients with heart disease receiving first-line treatment.

Meanwhile, Jaypirca’s second-quarter sales rose 56% year over year to $192 million. During the same period, BeiGene’s Brukinsa, the world’s top-selling BTK inhibitor, generated $1.2 billion in sales, up 31%.