The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
Antibody-drug conjugates combine targeting antibodies with powerful cytotoxic payloads, but clinical performance increasingly depends on linker chemistry, drug-to-antibody ratio, payload properties and how the medicine behaves inside heterogeneous tumors.
FDA approval moves Keytruda and Padcev into perioperative MIBC regardless of cisplatin eligibility, intensifying the contest for standard care.
Find out how Cellares’ FDA PreCheck selection could reshape automated cell therapy manufacturing while leaving product approval risks intact.
The new regimen replaces conventional chemotherapy with a Trop-2-directed antibody-drug conjugate while retaining PD-1 blockade, offering longer disease control but leaving overall survival, sequencing and cost questions unresolved.
AstraZeneca is funding a five-year YMCA cancer initiative that will begin in 75 communities, but its impact will depend on whether education leads to completed screenings, clinical referrals and sustained survivor support.
Find out how Antengene’s ATG-106 licensing deal could shape the next phase of solid tumor T cell engager development.
Find out how Voro Therapeutics and Alloy Therapeutics aim to advance safer masked T-cell engager cancer therapies.
Discover how LabGenius and LG Chem aim to use AI-designed multispecific antibodies to reduce solid-tumour toxicity and reshape oncology R&D.
Find out how Zai Lab’s zocilurtatug pelitecan could reshape DLL3-targeted cancer therapy as development risks remain.