Cisplatin

CHMP recommends approval after KEYNOTE-B15 showed event-free survival, overall survival and pathologic complete response gains; European Commission decision expected Q4 2026.

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.

First PD‑1 inhibitor plus ADC approved in EU as neoadjuvant then adjuvant therapy for cisplatin‑ineligible resectable muscle‑invasive bladder cancer.

KEYTRUDA plus Padcev improves survival and reduces recurrence in muscle-invasive bladder cancer, showing potential as a new standard for cisplatin-eligible patients.

FDA grants Breakthrough Therapy Designation to RYBREVANT FASPRO™ for HPV-unrelated head and neck cancer after platinum-based chemotherapy and PD-1/PD-L1 inhibitor.

Merck's KANDLELIT-007 trial tests calderasib and KEYTRUDA QLEX for KRAS G12C-mutant NSCLC, focusing on progression-free survival and overall response.

KEYTRUDA and Padcev improve survival and response rates in MIBC patients, showing promise as perioperative treatment with consistent safety profiles.

FDA approves first PD-1 inhibitor plus ADC regimens for cisplatin-ineligible muscle-invasive bladder cancer, based on KEYNOTE-905 trial results showing significant EFS improvement.

KEYTRUDA gains EU approval as the first anti-PD-1 therapy for resectable LA-HNSCC with PD-L1 expression, based on KEYNOTE-689 results.

FDA grants priority review for KEYTRUDA combinations with Padcev, showing improved survival in muscle-invasive bladder cancer patients ineligible for cisplatin-based chemotherapy.