02/02/2026 OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma Exelixis' NDA for zanzalintinib + atezolizumab in mCRC has been accepted for review by the US FDA TuHURA Biosciences' IFx-2.0 received the FDA orphan drug designation for cutaneous Melanoma OS Therapies initiated US FDA BLA filing for OST-HER2 for Osteosarcoma (Ref) OS Therapies has initiated a BLA submission to the US FDA for OST-HER2 (HER2-bioengineered form of Listeria monocytogenes) in the p

27/01/2026 Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma (Ref) The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-fi

26/01/2026 Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST (Ref) The US FDA granted the Breakthrough Therapy Designation to Cogent Biosciences' bezuclastinib (tyrosine kinase inhibitor) in combination with sunitinib for patients

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

06/01/2026 Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis (Ref) The US FDA granted the orphan drug designation to Cellenkos' CK0804 (CXCR4hi Treg therapeutic) for treatment of myelofibrosis. Dr. Simrit Parmar, MD, Founder, Cellenkos: "Receiving Orphan Drug Designation is an important

29/12/2025 HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma Genmab discontinued the clinical development of acasunlimab following a portfolio review HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma (Ref) China's NMPA accepted and granted priority review status to HUTCHMED Limited's NDA for fanregratinib (FGFR 1/2/3 inhibitor) for the treatment of a

23/12/2025 Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC SN Bioscience's SNB-101 received the FDA orphan drug designation for GC/GEJC Alphamab Oncology and 3D (Beijing) Medicines' envafolimab received the FDA orphan drug designation for GC/GEJC (Ref) The US FDA granted the orphan drug designation to Alphamab Oncology and 3D (Beijing) Medicines' envafolimab (KN035; subcutaneously injectable PD-L1 inhibitor) for t

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

16/12/2025 Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases Adagene's muzastotug + pembro received the FDA fast track designation for MSS mCRC without current or active liver metastases (Ref) The US FDA granted the fast track designation (FTD) to Adagene's muzastotug (ADG126; masked anti-CTLA-4) + pembrolizumab for the treatment of adult patients with microsatellite stable metastatic colorectal cance

09/12/2025 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies (Ref) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of re

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 th

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 pharmacok

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., Ly

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 familie

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 cancers

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 mDOR

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 Pharmaceuticals' Libtayo® (cemiplimab; PD-1 inhibitor) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The approval is based on results from the pivotal Phase 3 C-POST trial of adjuvant Libtayo vs placebo in patients with CSCC at high risk of recurrenc

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Jazz Pharmaceuticals' lurbinectedin (DNA alkylating agent) + Roche's atezolizumab (anti-PD-L1) as a maintenance Tx for adults with ES-SCLC whose disease has not progressed after first-line induction Tx with atezolizumab, carboplatin and etoposide. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel

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

02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma (Ref) The US FDA granted the Orphan Drug Designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of patients with neuroblastoma. Mark Burns, CSO and President, Aminex Therapeutics: "Receiving Orphan Drug Designation for AMXT 1501 in combination with DFMO represents an important milestone in our mission to