14/06/2026 Eli Lilly's Jaypirca Cuts Disease Progression Risk by 45% in Previously Treated CLL/SLL Eli Lilly's Jaypirca Cuts Disease Progression Risk by 45% in Previously Treated CLL/SLL (Ref) Eli Lilly announced positive Phase 3 BRUIN CLL-322 results for Jaypirca (pirtobrutinib) combined with venetoclax and rituximab in relapsed/refractory CLL/SLL, meeting its primary endpoint with a statistically significant 45% reduction in disease progression or death compared to venetocl

09/06/2026 Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref) Imugene's Azer-cel (azercabtagene zapreleucel; CD1

December 1st Week, 2025 Regulatory Events 🎯 The US FDA granted approval to Eli Lilly and Company 's pirtobrutinib (BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of the indication? 🎯 The US FDA granted approval to Bristol Myers Squibb 's lisocab

07/12/2025 In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL In Ph3 trial, Lilly's Jaypirca met its primary endpoint of ORR in CLL/SLL ( Ref ) The Phase 3 BRUIN CLL-314 trial of Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) met its primary endpoint of non-inferiority on ORR vs ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. ORR: 87.0%

03/12/2025 Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL Eli Lilly and Company's pirtobrutinib received the FDA approval for R/R CLL/SLL ( Ref ) The US FDA granted approval to Eli Lilly and Company's pirtobrutinib (Jaypirca; BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. This approval con

August 1st Week, 2025 Regulatory Events 🎯 AbbVie submitted a sNDA to the US FDA for AbbVie and Roche ’s venetoclax (BCL-2...