Optimal Dose https://validator.w3.org/feed/docs/rss2.html Optimal Dose – CAR-T Digest (August 2020) Trastuzumab Ruikang has received BTD from China’s NMPA for the treatment of HER2‑positive breast cancer Weekly News 18 April to 24 April 2026 Weekly News 18 April to 24 April 2026 SHR‑A2102 has received BTD from China’s NMPA for the treatment of cervical cancer U.S. FDA grants Priority Review to sBLA for PADCEV + Keytruda as perioperative treatment for MIBC regardless of Cisplatin eligibility Mabwell initiates phase 3 clinical study of its Nectin-4 targeting ADC 9MW2821 for the treatment of TNBC Blenrep approved in China for treatment of 2L+ relapsed/refractory multiple myeloma Servier completes the acquisition of Day One Biopharmaceuticals Kelun-Biotech announces phase 3 trial of Sacituzumab Tirumotecan versus Chemotherapy as 1L treatment for advanced TNBC met primary endpoint of PFS Hengrui announces phase 3 trial of HER3 ADC SHR-A2009 for EGFR-mutant advanced NSCLC met primary endpoint of PFS Weekly News 16 May to 22 May 2026 Weekly News 16 May to 22 May 2026 TroFuse-005 trial evaluating Sacituzumab Tirumotecan met primary endpoints of OS and PFS in certain patients with advanced or recurrent Endometrial cancer PADCEV in combination with Keytruda receives positive CHMP opinion for the treatment of patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy CDSCO approves Astellas’ PADCEV for first-line advanced Bladder cancer treatment ENHERTU approved in the US for two new indications for patients with HER2-positive early Breast cancer 3B Pharmaceuticals and TetraKit Technologies announce strategic collaboration for joint radioligand therapy (RLT) development Ifinatamab Deruxtecan receives U.S. Priority Review for previously treated extensive-stage SCLC progressing after platinum-based chemotherapy Weekly News 11 April to 17 April 2026 Weekly News 11 April to 17 April 2026 CSPC Pharmaceutical Group Limited obtains NMPA clinical trial approval for TF-targeted ADC SYS6051 in China CrossBridge Bio enters an agreement to be acquired by Eli Lilly to advance next-generation dual-payload ADCs GlycoNex receives PMDA approval in Japan to initiate first-in-human phase 1 trial of GNX1021 in gastrointestinal cancers HS-20093 granted Breakthrough Therapy Designation by NMPA for Esophageal cancer treatment Weekly News 09 May to 15 May 2026 Weekly News 09 May to 15 May 2026 Astellas Pharma sNDA in Japan for PADCEV in combination with Keytruda for cisplatin-eligible patients with muscle-invasive Bladder cancer Emiltatug Ledadotin has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Adenoid cystic carcinoma Zai Lab announced that Zocilurtatug Pelitecan has received U.S. FDA FTD for the treatment of extrapulmonary Neuroendocrine carcinomas SYS6010 has received another BTD in China for the treatment of patients with locally advanced or metastatic ESCC The sNDA for Sacituzumab Tirumotecan in combination with Pembrolizumab as 1L treatment for PD-L1 positive NSCLC accepted for review by NMPA Daiichi Sankyo Korea and AstraZeneca Korea received approval for two additional Enhertu indications: 1L HER2-positive metastatic breast cancer and 2L HER2-positive metastatic gastric cancer Weekly News 02 May to 08 May 2026 Weekly News 02 May to 08 May 2026 Waiv enters collaboration with Daiichi Sankyo to deliver AI-derived biomarkers for ADC program Bristol Myers Squibb licenses Antibody-Drug Conjugate technology from Lonza ArriVent announces IND clearance for novel tetravalent MUC16/NaPi2b targeting ADC ARR-002 with initial focus in ovarian and endometrial cancers InnoCare Pharma’s independently developed CDH17-targeted ADC innovative drug ICP B208 has been approved for clinical trials HLX43 received PMDA acknowledgment to initiate a global Phase 2/3 trial in squamous non-small cell lung cancer Tacalyx secures €11 million to advance lead TACA-targeting ADC programme toward the clinic SYS6051 obtains clinical trial approval in the U.S. Weekly News 25 April to 01 May 2026 Weekly News 25 April to 01 May 2026 Novartis withdraws EMA application for adding new indication for Pluvicto Taiho Pharmaceutical and Araris Biotech AG advance ADC ARC-02 into phase 1 clinical development Alphamab Oncology announces IND application for TROP2/HER3 bispecific ADC JSKN016SC officially accepted by CDE The NMPA has granted BTD for B7-H3-targeted ADC HS-20093 for castration-resistant prostate cancer Monthly Digest – May 2026 Monthly Digest – May 2026