ADDED
Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2025 based on the closing price on June 30, 2025, the last business day of the registrant s most recently completed second fiscal quarter: approximately $ 198,051,000,000 .
Risk Factors 26 Cautionary Factors that May Affect Future Results 41 Item 1B.
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) is a subcutaneously-administered fixed combination of pembrolizumab, an anti-PD-1 therapy, and berahyaluronidase alfa, which enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab.
In some markets, it is approved as a new subcutaneous route of administration and new pharmaceutical form of Keytruda and is marketed as Keytruda SC .
Welireg (belzutifan) is a medication for the treatment of adult patients with certain von Hippel-Lindau (VHL) disease-associated tumors not requiring immediate surgery, for the treatment of adult patients with advanced RCC following a PD-1 or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (TKI) and for treatment of adult and pediatric patients 12 years and older with certain types of pheochromocytoma or paraganglioma.
Product Approvals Set forth below is a summary of significant product approvals received by the Company in 2025 and, to date, in 2026.
Product Date Approval Keytruda January 2025 China s National Medical Products Administration (NMPA) approval in combination with enfortumab vedotin, an antibody-drug conjugate (ADC), for the treatment of adults with locally advanced or metastatic urothelial carcinoma, based on the KEYNOTE-A39 trial that was conducted in collaboration with Seagen (now Pfizer Inc., Pfizer) and Astellas.
April 2025 European Commission (EC) approval in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable non epithelioid malignant pleural mesothelioma, based on the IND.227/KEYNOTE-483 trial.
May 2025 Japan s Ministry of Health, Labor and Welfare (MHLW) approval in combination with trastuzumab and chemotherapy for the first-line treatment of patients with unresectable, advanced or recurrent HER2-positive gastric or GEJ adenocarcinoma, based on the KEYNOTE-811 trial.
May 2025 Japan s MHLW approval in combination with pemetrexed and platinum chemotherapy for unresectable, advanced or recurrent metastatic malignant pleural mesothelioma, based on the IND.227/KEYNOTE-483 trial.
REMOVED
Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 28, 2024 based on the closing price on June 28, 2024, the last business day of the registrant s most recently completed second fiscal quarter: approximately $ 313,799,000,000 .
Risk Factors 26 Cautionary Factors that May Affect Future Results 40 Item 1B.
Additionally, Keytruda is approved for patients with certain types of resectable NSCLC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
Keytruda is also approved for certain patients with high-risk early stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
Welireg (belzutifan) is a medication for the treatment of adult patients with certain von Hippel-Lindau (VHL) disease-associated tumors not requiring immediate surgery, and for the treatment of adult patients with advanced RCC following a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.
Hospital Acute Care Bridion (sugammadex), a medication for the reversal of two types of neuromuscular blocking agents used during surgery; Prevymis (letermovir) for the prophylaxis of cytomegalovirus (CMV) infection and disease, or of CMV disease, in certain high risk adult and pediatric recipients of an allogeneic hematopoietic stem cell transplant or of a kidney transplant, respectively; Dificid (fidaxomicin) for the treatment of C.
difficile -associated diarrhea; Zerbaxa (ceftolozane and tazobactam) for injection, a combination antibacterial and beta-lactamase inhibitor for the treatment of certain bacterial infections; and Noxafil (posaconazole), an antifungal agent for the prevention of certain invasive fungal infections.
Product Approvals Set forth below is a summary of significant product approvals received by the Company in 2024 and, to date, in 2025.
Food and Drug Administration (FDA) approval in combination with chemoradiotherapy for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer, based on the KEYNOTE-A18 trial.
January 2024 FDA full approval for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1 containing regimen.