Weekly Digest – October 2025 Weekly Digest – October 2025 30 September 2025: AbbVie submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) an investigational ADC to treat rare cancer with limited treatment options AbbVie has submitted […]
Weekly Digest – October 2025 Weekly Digest – October 2025 01 October 2025: Enhertu followed by THP supplemental biologics license application accepted in the U.S. for patients with high-risk HER2 positive early-stage breast cancer prior to surgery The U.S. FDA […]
Weekly Digest – October 2025 Weekly Digest – October 2025 30 September 2025: Henlius receives the NMPA IND approval for Its PD-L1 targeting ADC HLX43 in combination with novel anti-EGFR mAb HLX07 The China NMPA approved Henlius’ IND application for […]
Weekly Digest – February 2025 Weekly Digest – February 2025 26 Feb 2025: Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer The FDA has granted Fast Track Designation […]
Weekly Digest – February 2025 Weekly Digest – February 2025 25 Feb 2025: Hansoh Pharma’s HS-20093 receives Breakthrough Therapy Designation from NMPA for Osteosarcoma Hansoh Pharma’s B7-H3-targeted ADC, HS-20093, has been granted Breakthrough Therapy Designated Drug status by China’s NMPA […]
ADC Digest – August 2020 ADC Digest – August 2020 Kadcyla approved in Japan for adjuvant therapy of HER2-positive early breast cancer 21 Aug 2020 Kadcyla (Trastuzumab emtansine, Tubulin polymerization inhibitor; Chugai (a Roche subsidiary)/Immunogen) Approval was based on the […]
ADC Digest – August 2020 ADC Digest – August 2020 AstraZeneca in collaboration with Daiichi Sankyo initiated a Phase 3 study evaluating trastuzumab deruxtecan versus chemotherapy in HER2-low, HR+ breast cancer 20 Aug 2020 Enhertu (Trastuzumab deruxtecan, DNA topoisomerase I […]
ADC Digest – August 2020 ADC Digest – August 2020 Immunomedics announced FDA approval of Samsung Biologics as antibody manufacturer of Trodelvy 17 Aug 2020 Trodelvy: (Sacituzumab govitecan-hziy, DNA topoisomerase I inhibitor; Immunomedics) Immunomedics announced that the FDA has approved […]
ADC Digest – August 2020 ADC Digest – August 2020 Mersana Therapeutics received FDA fast track designation (FTD) for XMT-1536 for the treatment of patients with platinum-resistant ovarian cancer 11 Aug 2020 XMT-1536 (NaPi2b antibody; Mersana Therapeutics/Recepta Biopharma) FDA has […]
ADC Digest – August 2020 ADC Digest – August 2020 FDA approved GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma 06 Aug 2020 BLENREP (belantamab mafodotin-blmf, Tubulin polymerisation inhibitors; GSK) Approved as monotherapy […]
