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urothelial cancer

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FDA approval of Padcev plus Keytruda expands perioperative treatment options for adults with muscle-invasive bladder cancer regardless of cisplatin eligibility. Representative image.
Pharma & Biotech

Pfizer and Astellas secure wider FDA label for Padcev plus Keytruda in muscle-invasive bladder cancer

FDA expands Padcev plus Keytruda to adults with muscle-invasive bladder cancer regardless of cisplatin eligibility, reshaping perioperative care.

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Representative image: Endoscopic bladder procedure scene highlighting UroGen Pharma’s UGN-501 clearance and the next-stage search for intravesical oncolytic virus therapy in non-muscle invasive bladder cancer.
Pharma & Biotech

Could UroGen Pharma’s oncolytic virus open the next chapter in bladder cancer therapy?

UroGen Pharma Ltd. (Nasdaq: URGN) has received U.S. Food and Drug Administration clearance of its Investigational New Drug application for UGN-501, an investigational next-generation oncolytic virus for non-muscle invasive bladder cancer. The clearance enables the urothelial cancer-focused biotechnology company to begin a planned Phase 1 trial of local intravesical administration, with patient enrollment expected to

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Representative image: A clinician reviews bladder cancer imaging in a modern oncology setting, reflecting Merck’s KEYTRUDA plus Padcev EU regulatory milestone for cisplatin-ineligible muscle-invasive bladder cancer patients.
Pharma & Biotech

Why Merck’s CHMP win for KEYTRUDA plus Padcev matters in muscle-invasive bladder cancer

Merck’s bladder cancer push is moving earlier in Europe. KEYTRUDA plus Padcev could reset cisplatin-ineligible MIBC care.

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A representative image of bladder cancer treatment. As PADCEV and Keytruda show promise in transforming perioperative care, new platinum-free regimens are reshaping how muscle-invasive bladder cancer is managed.
Pharma & Biotech

PADCEV plus Keytruda meets survival endpoints in cisplatin-eligible bladder cancer patients

Astellas Pharma Inc. and Pfizer Inc. have announced that their antibody-drug conjugate PADCEV (enfortumab vedotin), in combination with the PD-1 inhibitor pembrolizumab (marketed as Keytruda by Merck), met key survival endpoints in the Phase 3 EV-304 trial. In cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), the combination significantly improved both event-free survival and overall survival

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