FDA Approves Jaypirca for Previously Untreated CLL and SLL

The U.S. Food and Drug Administration approved Jaypirca (pirtobrutinib) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a known 17p deletion. This regulatory decision introduces a new treatment option for eligible patients in this category.

The approval, announced on October 2, 2026, applies to patients who have not received prior therapy for CLL or SLL and have no evidence of the 17p deletion genetic abnormality. The FDA's decision followed a review of clinical trial results comparing Jaypirca to established therapies.

Eli Lilly and Company stated that Jaypirca is now authorized for use as a first-line treatment for appropriate CLL and SLL patients without the 17p deletion. The company also described Jaypirca as the first and only non-covalent (reversible) BTK inhibitor approved by the FDA.

According to the FDA, the approval was based on data from the Phase 3 BRUIN CLL-313 trial. This study evaluated pirtobrutinib against a combination of bendamustine and rituximab in previously untreated patients with CLL or SLL who did not have the 17p deletion.

What the numbers show

• FDA approval date: October 2, 2026.
• Jaypirca is approved for adults with untreated CLL or SLL without 17p deletion.
• The Phase 3 BRUIN CLL-313 trial supported the approval.

Jaypirca is the first FDA-approved BTK inhibitor that works through a non-covalent, reversible mechanism. This distinguishes it from other BTK inhibitors previously authorized for similar indications.

The clinical trial supporting the approval included patients who had not received previous treatment for CLL or SLL and did not have the 17p deletion. The study compared Jaypirca to a regimen of bendamustine plus rituximab, which is a standard therapy for these conditions.

Eli Lilly and Company announced that the FDA's approval allows Jaypirca to be prescribed as an initial therapy for eligible patients. The company highlighted the unique mechanism of Jaypirca as a non-covalent BTK inhibitor in its statement.

The FDA confirmed that the approval was based on the results of the Phase 3 clinical trial, which provided the necessary data to support the use of Jaypirca in this patient population. The agency published details of the approval on its official website.

* This article is based on publicly available information at the time of writing.