01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia ( Ref ) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL ( Ref ) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.  The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmac

18/11/2025 AbbVie and Genmab's epcoritamab + rituximab + lenalidomide received FDA approval for R/R FL ( Ref ) The US FDA granted approval to AbbVie and Genmab's epcoritamab (bispecific CD20-directed CD3 T-cell engager) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).  The approval is based on results from the Phase 3 EPCORE FL-1 trial of the combo vs rituximab and lenalidomide Lorenzo Falchi, M.D.,

11/11/2025 Allterum Therapeutics' 4A10 received the FDA fast track designation for ALL ( Ref ) The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). Yan Moore, CEO, Allterum Therapeutics: " The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and fami

05/11/2025 Leukogene Therapeutics' LTI-214 received the FDA orphan drug designation for AML ( Ref ) The US FDA granted the orphan drug designation to Leukogene Therapeutics' LTI-214 (M2T-CD33; myeloid-targeted immunotherapy) for the treatment of Acute Myeloid Leukemia (AML). Sandeep Gupta, CEO, Leukogene: “ We are honored that the FDA has recognized the therapeutic promise of LTI-214 by granting Orphan Drug Designation. AML remains one of the most challenging hematologic canc

03/11/2025 Iovance's lifileucel TIL therapy elicited an ORR of 25.6% in previously treated non-sq NSCLC ( Ref ) Iovance Biotherapeutics reported interim data from its registrational Phase 2 IOV-LUN-202/NCT04614103 trial of lifileucel monotherapy (autologous TIL therapy) in patients with previously treated advanced non-squamous NSCLC without actionable genetic mutations. An ORR of 25.6% (CR: 5.1%) was achieved in a pool of 39 patients At a median follow up of 25.4 mos, the mDO

08/10/2025 Regeneron's cemiplimab has been approved by the US FDA for the adjuvant Tx of CSCC ( Ref ) The US FDA approved Regeneron...

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Jazz Pharmaceuticals ' lurbinectedin (DNA alkylating agent) +  Roche 's...

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma ( Ref ) The US FDA granted...

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction ( Ref ) Genmab and Merus announced a transaction...

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...

15/09/2025 Daiichi and Merck's raludotatug deruxtecan received the Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or...

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer ( Ref ) The US FDA granted...

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC ( Ref ) The US FDA...

31/07/2025 MaxCyte and Anocca AB signed a Strategic Platform Licensing Agreement to advance TCR-T cell therapies ( Ref ) MaxCyte signed a...

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (...

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA...

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA ( Ref ) The US FDA issued a Complete...

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC ( Ref ) The European Commission granted marketing...