Cipla’s Invagen has licensed U.S. rights to Qilu’s investigational pembrolizumab biosimilar QL2107, setting up a future challenge to Merck’s blockbuster Keytruda franchise.
FDA raised no objection to a randomized Phase 3 comparing neoadjuvant ruxotemitide plus pembrolizumab with pembrolizumab alone and indicated that one well-controlled study could potentially support an NDA.
FDA Fast Track gives spevatamig a faster regulatory path in biliary tract cancer as Phanes advances its Phase 2 and pembrolizumab strategy.
Kelun-Biotech reports improved Phase III PFS with sac-TMT plus pembrolizumab, while survival and detailed safety data remain pending.
FDA approval moves Keytruda and Padcev into perioperative MIBC regardless of cisplatin eligibility, intensifying the contest for standard care.
FDA expands Padcev plus Keytruda to adults with muscle-invasive bladder cancer regardless of cisplatin eligibility, reshaping perioperative care.
Read how Samsung Bioepis SB27’s positive Phase 1 and Phase 3 data could reshape the Keytruda biosimilar race and oncology access.
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.
Discover why Pfizer’s sigvotatug vedotin Phase 3 miss shifts attention to second-line patients, biomarkers and first-line combinations.
Find out how Merck’s Keytruda and Welireg approval could reshape adjuvant clear cell renal cell carcinoma treatment.