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
Jaypirca (pirtobrutinib) recommended by CHMP for approval in the EU for adults with R/R CLL previously treated with a BTKi March 4, 2025
NDA for Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA November 19, 2024
Fixed-duration Calquence + venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial August 7, 2024
Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial July 30, 2024
