Core Insights - The FDA has approved both intravenous and subcutaneous formulations of Merck's Keytruda in combination with Pfizer's Padcev for treating muscle-invasive bladder cancer in patients ineligible for cisplatin-based chemotherapy [1][2][6] Regulatory Approvals - Keytruda and Keytruda Qlex have been approved as neoadjuvant and adjuvant treatments for adult patients with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy [2][8] - This marks the first approval of a PD-1 inhibitor plus ADC regimen for this specific patient population [2] Clinical Trial Data - The approvals were based on the phase III KEYNOTE-905 trial, which demonstrated a 60% reduction in the risk of event-free survival and a 50% improvement in overall survival compared to surgery alone [4][7][6] Financial Performance - Keytruda generated sales of $23.30 billion in the first nine months of 2025, reflecting an 8% year-over-year increase [9] - Padcev, part of Pfizer's oncology portfolio, generated $1.43 billion in sales during the same period, marking a 25% year-over-year increase [9] Market Context - Year to date, Merck's shares have decreased by 1.7%, while the industry has seen a rise of 16.1% [3]