Jaypirca (pirtobrutinib) recommended by CHMP for approval in the EU for adults with CLL across all lines of therapy July 21, 2026
Eleven sites open for patient enrollment in TakeAim CLL combination study with zanubrutinib June 30, 2026
TCX-001 approved by SwissMedic for First-in-Human Ph 1 trial in patients with R/R AML and CLL June 17, 2026
European Commission Authorizes Expanded Label for VENCLYXTO® (venetoclax) to Include Additional Combinations in 1L CLL June 2, 2026
Jaypirca (pirtobrutinib) significantly extended PFS when added to a venetoclax time-limited regimen in patients with previously treated CLL/SLL April 21, 2026
Calquence + venetoclax approved in the US as oral, fixed-duration combination for 1L CLL patients February 25, 2026
FDA approves expanded indication for Jaypirca (pirtobrutinib) for adults with R/R CLL/SLL previously treated with a covalent BTK inhibitor December 9, 2025
New Data Announced from Ph 1b/2 EPCORE® CLL-1 Trial of Epcoritamab as Monotherapy and in Combination for Patients with Richter Transformation (RT) December 9, 2025
Gazyva® IV Infusion 1000 mg revised to allow combination therapy with the Venclexta® Tablets 10 mg, 50 mg, and 100 mg for 1L CD20-positive CLL/SLL November 24, 2025
Jaypirca significantly improved PFS in patients with treatment-naïve CLL/SLL in the Ph 3 BRUIN CLL-313 study September 9, 2025
Supplemental NDA submitted to FDA for fixed-duration, all-oral combo regimen of VENCLEXTA and acalabrutinib in 1L CLL patients August 5, 2025
Jaypirca (pirtobrutinib) met primary endpoint in a head-to-head Ph 3 trial versus Imbruvica (ibrutinib) in CLL/SLL August 5, 2025
Lisaftoclax (APG-2575) approved by China’s NMPA for the treatment of adult 2L+ CLL/SLL patients July 15, 2025
Fixed-duration Calquence-based regimens approved in EU for 1L CLL patients based on AMPLIFY Ph 3 trial results June 11, 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for 1L CLL May 6, 2025
First Patient Dosed in the Ph 3 Registrational Trial of ICP-248 + Orelabrutinib as First-Line Therapy for Treatment of CLL/SLL Patients in China April 2, 2025
