13/01/2026 Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML Ipsen's IPN60340 received the FDA Breakthrough Therapy Designation for AML (Ref) The US FDA granted the Breakthrough Therapy Designation to Ipsen's IPN60340 (anti-BTN3A) in combination with venetoclax and azacitidine in first line unfit acute myeloid leukemia. Christelle Huguet, PhD, EVP and Head of R&D, Ipsen: “This Breakthrough Therapy Designation recognizes both the urgent need for new tr

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% [

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC (Ref) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. The

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies (Ref) The US FDA accepted Orca Bio's BLA seeking approval for Orca-T (allogeneic T-cell immunotherapy) as a treatment for hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes. Priority Review status has been granted with a PDUFA target action date of April 6, 2026 The BLA submission was based on positive resul

27/08/2025 BeOne Medicines' perioperative tislelizumab regimen received approval from the EC for resectable NSCLC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + platinum-containing chemotherapy as neoadjuvant treatment followed by tislelizumab monotherapy as adjuvant treatment for adult patients with resectable NSCLC at high risk of recurrence. The approval was based on results from the China-specific Phase 3 RATIONALE-315 trial Per pre-planned fi

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia (Ref) The US FDA granted the Orphan Drug Designation to ImCheck Therapeutics' ICT01 (anti-BTN3A) for the treatment of acute myeloid leukemia Stephan Braun, CMO, ImCheck Therapeutics: "Receiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01’s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients. This important regulatory m