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.
INTerpath-001 met recurrence-free and distant metastasis-free survival endpoints in 1,137 patients, giving individualized mRNA cancer therapy its first positive Phase 3 readout.
CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic TNBC, moving Gilead closer to an expanded EU label.
CEL-SCI launches a 212-patient Multikine Phase 3 study, but subgroup validation, funding and regulatory execution remain decisive.
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.
The decision gives clinicians a Trodelvy-based option for patients who cannot receive checkpoint inhibitors and a Trodelvy plus Keytruda regimen for PD-L1-positive disease. The immediate clinical impact is substantial, although immature overall-survival data, toxicity management and treatment cost will influence how rapidly the new pathways displace chemotherapy.
Find out how Merck’s Keytruda and Welireg approval could reshape adjuvant clear cell renal cell carcinoma treatment.