FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
MSD said sacituzumab tirumotecan improved overall survival and progression-free survival in the Phase III TroFuse-005 trial in endometrial cancer. The study also met its objective response rate endpoint.
Regeneron and Parabilis Medicines entered a research collaboration focused on Antibody-Helicon Conjugates. The deal includes $125 million upfront and financing support and up to $2.2 billion in milestones.
The global antibody drug conjugate market is calculated at USD 14.76 billion in 2026 and is expected to reach USD 32.66 billion by 2035. North America held a 53% share in 2025, while Asia Pacific is projected to grow fastest.
BioNTech enters May with first-quarter earnings due May 5 and a May 15 shareholder vote on a capital increase. The company is pushing its oncology pipeline as COVID-19 vaccine sales decline.
The global cancer monoclonal antibodies market was valued at USD 66.7 billion in 2025 and is expected to reach USD 135.2 billion by 2033. Growth is being driven by targeted therapies, bispecific antibodies, ADCs and checkpoint inhibitors.
The global API market is projected to grow to USD 198.39 billion by 2030 from USD 144.20 billion in 2025, at a 6.6% CAGR. Oncology, rare disease and diabetes pipelines are key growth drivers.
Daiichi Sankyo is collaborating with BostonGene to integrate AI-driven translational intelligence into an antibody drug conjugate development programme. The work is aimed at biomarker discovery, response prediction, patient selection and trial design across its cancer pipeline.
Celltrion said CT-P71 received FDA Fast Track designation for previously treated locally advanced or metastatic urothelial cancer. The ADC candidate is in Phase 1 testing.
The FDA granted fast track designation to SIM0505, a CDH6-targeting antibody-drug conjugate, for platinum-resistant ovarian cancer based on preclinical and early clinical data. A phase 1 trial is currently evaluating the drug in advanced solid tumors, with initial data expected at the 2026 ASCO conference. The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026.