July 10, 2026
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The FDA has approved two immunotherapy combination therapies for adults with muscle-invasive bladder cancer. Pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) was approved as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with
July 10, 2026
1 min read
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FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC)

FDA Expands Approval of Chemo-Free Bladder Cancer Combo in Curative Setting

U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

Pfizer, Astellas Expand PADCEV-Keytruda Label With FDA Nod In Bladder Cancer - Pfizer (NYSE:PFE)

Star Padcev-Keytruda combo expands bladder cancer reach with FDA approval, pressuring AstraZeneca

FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev®…

Perioperative Keytruda-Padcev for MIBC approved regardless of cisplatin eligibility

The FDA has approved atezolizumab and atezolizumab with hyaluronidase-tqjs as adjuvant treatment for certain adults with muscle…

The FDA approved belzutifan with pembrolizumab as an adjuvant treatment for adults with clear cell renal cell carcinoma and a…

U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of…

FDA approves Pfizer and Astellas' PADCEV plus Keytruda for muscle-invasive bladder cancer, backed by Phase 3 survival data.