China’s National Medical Products Administration (NMPA) has approved the non-covalent BTK inhibitor pirtobrutinib (Jaypirca) as a treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) across all lines of therapy and regardless of prior exposure to covalent BTK inhibitors, according to a press release from the developer, Innovent Biologics.1
What data supported the approval of pirtobrutinib in China?
The NMPA based its decision on data from the phase 3 BRUIN CLL-313 (NCT05023980) and BRUIN CLL-314 trials (NCT05254743). In BRUIN CLL-313, pirtobrutinib reduced the risk of disease progression or death by 80.1% vs bendamustine (Treanda) plus rituximab (Rituxan) per independent review committee (IRC) assessment. This represented a statistically significant improvement in progression-free survival (PFS) with pirtobrutinib.
“BTK inhibitors have significantly transformed the treatment landscape for patients with CLL/SLL in recent years. However, as disease management continues to evolve, there remains a growing need for treatment options that combine durable efficacy with a favorable tolerability profile. As a non-covalent BTK inhibitor, pirtobrutinib has demonstrated meaningful clinical benefit in both treatment-naïve and previously treated patients with CLL/SLL,” BRUIN CLL-313 investigator Jianyong Li, MD, PhD, professor and director of the Department of Hematology at First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, stated in the press release.1 “This approval has the potential to provide a new option for Chinese patients with CLL/SLL across all lines of therapy, meaningfully advancing the management of CLL/SLL throughout the treatment journey.”
Data from the BRUIN CLL-314 trial, the first study to compare covalent and noncovalent BTK inhibition among patients without prior exposure to BTK inhibitors, showed that pirtobrutinib reached the primary end point of noninferiority for overall response rate (ORR) vs ibrutinib (Imbruvica). Pirtobrutinib demonstrated a numerically higher ORR, and although PFS data were immature at the time of analysis, a trend towards improved PFS with pirtobrutinib was reported.
“With the emergence of non-covalent BTK inhibitors, the treatment landscape for CLL or SLL is rapidly evolving,” BRUIN CLL-314 investigator Luqiu Qiu MD, head of Department at China Academy of Chinese Medical Sciences, said in the press release.1 “Pirtobrutinib’s novel head-to-head evidence against a covalent BTK inhibitor in a BTK inhibitor-naïve population, may offer an important treatment option for both treatment-naïve and relapsed or refractory patients, regardless of prior covalent BTK inhibitor treatment.”
How were the BRUIN CLL-313 and BRUIN CLL-314 trials designed?
Investigators of the international, open-label BRUIN CLL-313 trial assessed pirtobrutinib vs chemoimmunotherapy with bendamustine/rituximab among patients with previously untreated CLL/SLL and no 17p deletions. A total of 282 patients were randomly assigned 1:1 to receive pirtobrutinib at 200 mg once daily or bendamustine/rituximab.
The primary end point of BRUIN CLL-313 was PFS per blinded independent review committee (BICR) assessment. Secondary end points included ORR, duration of response (DOR), PFS, overall survival (OS), time to next treatment, and safety.
The BRUIN CLL-314 study was designed as an open-label, non-inferiority phase 3 trial to evaluate pirtobrutinib vs ibrutinib among 662 patients with CLL or SLL. Patients were randomly assigned 1:1 to receive pirtobrutinib at 200 mg orally once daily or ibrutinib at 420 mg orally once daily.
The primary end point of BRUIN CLL-314 was ORR per BICR. Secondary end points included PFS, DOR, event-free survival, time to next treatment, OS, and safety.
The FDA previously approved pirtobrutinib for patients with CLL or SLL who previously received a BTK inhibitor in December 2025 based on data from the phase 3 BRUIN-CLL-321 trial (NCT04666038).2 Additionally, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of pirtobrutinib for CLL across all lines of treatment in June 2026 based on data from BRUIN CLL-313 and BRUIN CLL-314.3
References
- Jaypirca® (pirtobrutinib) approved in China for a new indication in chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) across all lines of therapy. News release. Innovent Biologics, Inc. September 28, 2026. Accessed September 28, 2026.https://tinyurl.com/2s3aa7pz
- FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. News release. December 3, 2025. Accessed September 28, 2026. https://tinyurl.com/3tyaw463
- Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy. News release. Eli Lilly and Company. June 26, 2026. Accessed September 28, 2026. https://tinyurl.com/ek23sse6
