30/06/2026 BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL (Ref) BeOne Medicines announced that BRUKINSA (zanubrutinib; BTK inhibitor) combined with rituximab met the primary progression-free survival endpoint in the Phase 3 MANGROVE

27/04/2026 Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDU

18/12/2025 BeOne Medicines' BGB-B2033 received the FDA fast track designation for HCC BeOne Medicines' BGB-B2033 received the FDA fast track designation for HCC (Ref) The US FDA granted the fast track designation to BeOne Medicines' BGB-B2033 (GPC3 x 4-1BB BsAb) for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment. Julie Lepin, SVP and Chief Regulatory Affairs Officer, BeOne: “The FDA awards Fast

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

29/08/2025 BeOne reported positive topline results for sonrotoclax in R/R MCL (Ref) BeOne Medicines' Phase 1/2 BGB-11417-201 trial of sonrotoclax (BCL2 inhibitor) met its primary endpoint of ORR in adult patients with relapsed/refractory mantle cell lymphoma following treatment with a BTK inhibitor and anti-CD20 therapy. Promising results were also observed across several secondary efficacy endpoints, including CR, DOR and PFS The safety profile was generally well-tolerated,

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

24/07/2025 GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic cancer (Ref) The US FDA granted the Fast Track Designation to GenFleet Therapeutics and Verastem Oncology's VS-7375 (oral KRAS G12D (ON/OFF) inhibitor) for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas, and for the treatment of patients with KRAS G12D-mutated locally adva

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)