Also known as KEYTRUDA and KEYTRUDA®.
First subcutaneous immune‑checkpoint inhibitor in Japan; can be given in as little as one minute and showed comparable exposure and response to IV pembrolizumab in a phase‑3 trial.
CHMP recommends approval after KEYNOTE-B15 showed event-free survival, overall survival and pathologic complete response gains; European Commission decision expected Q4 2026.
Approval allows FoundationOne CDx to detect BRAF V600 alterations and BRAF fusion genes to guide tovorafenib treatment in glioma and expands companion indications to nine cancer types.
First Phase 3 success for an individualized mRNA neoantigen therapy; trial met RFS and DMFS in completely resected stage IIB–IV melanoma; OS pending; safety consistent.
Breakthrough designation covers olomorasib monotherapy for adults with advanced pancreatic cancer harboring KRAS G12C after at least one prior systemic therapy.
Phase 3 trial finds pembrolizumab monotherapy improves PFS versus platinum doublet chemotherapy in dMMR advanced or recurrent endometrial cancer.
FDA clears PD‑1 inhibitor plus antibody‑drug conjugate regimens with enfortumab vedotin as neoadjuvant and adjuvant therapy around cystectomy for adults with muscle‑invasive bladder cancer.
Head‑to‑head phase III in previously treated KRAS G12C NSCLC: divarasib improved progression‑free and overall survival versus sotorasib/adagrasib with a consistent safety profile.
Head-to-head Phase III shows divarasib improves progression-free and overall survival versus sotorasib/adagrasib; safety consistent; data to be filed and presented.
First PD‑1 inhibitor plus ADC approved in EU as neoadjuvant then adjuvant therapy for cisplatin‑ineligible resectable muscle‑invasive bladder cancer.
