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KEYTRUDA® (Pembrolizumab) Plus LENVIMA® (Lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma.” Merck, 17 Sept

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KEYTRUDA® (Pembrolizumab) Plus LENVIMA® (Lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma.” Merck, 17 Sept Keytruda (pembrolizumab) Page Indication Date Approved Date Updated 2 Endometrial Carcinoma Sept 17, 2019 Sept 19, 2019 Squamous Cell Carcinoma of the 3 July 30, 2019 July 31, 2019 Esophagus 4 Small-Cell Lung Cancer June 17, 2019 June 18, 2019 5 Metastatic Renal Cell Carcinoma April 19, 2019 May 9, 2019 6 Melanoma Feb 15, 2019 May 9, 2019 7 Merkel Cell Carcinoma Dec 19, 2018 Feb 1, 2019 8 Hepatocellular Carcinoma Nov 9, 2018 Feb 1, 2019 9 Primary Mediastinal B-Cell Lymphoma June 13, 2018 Feb 1, 2019 10 Cervical Cancer June 12, 2018 Feb 1, 2019 Adenocarcinoma Of The Gastroesophageal 11 Sept 22, 2017 Feb 1, 2019 Junction 12 Microsatellite Instability-High Cancer May 23, 2017 Feb 1, 2019 Metastatic Transitional (Urothelial) Tract 13 May 18, 2017 Feb 1, 2019 Cancer Hodgkin Lymphoma (B-Cell Hodgkin 14 March 14, 2017 Feb 1, 2019 Lymphoma) Recurrent Head and Neck Squamous Cell June 10, 2019 15 June 11, 2019 Carcinoma Aug 5, 2016 April 11, 2019 Oct 2, 2015 16 Non-Small Cell Lung Cancer May 9, 2019 Oct 24, 2016 May 10, 2017 17 Metastatic Melanoma Sept 4, 2014 Feb 1, 2019 1 Drug Information Regulatory Information Manufacturer: Merck Application Type: Supplemental BLA Drug Brand Original Anticipated Approval N/A Name: Keytruda (PDUFA): Regulatory Status: Approved Regulatory Status Date: Drug Generic 9/17/2019 pembrolizumab Name: Regulatory Status Reason: N/A Orphan Drug Designation: N/A Drug Type: Monoclonal Antibody FDA Fast Track Designation: N/A Route of Breakthrough Therapy 7/31/2018 Administration: Intravenous Designation Priority Review Designation: N/A Indication Details Sales Forecast Indication Incidence Incidence Type Endometrial U.S. 61,880 * Carcinoma Global N/A Source: GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com , Accessed: Sep 19, 2019. Comments Section On September 17, 2019, FDA approved Keytruda (pembrolizumab), in combination with lenvatinib, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Endometrial Cancer Prevalence (US, 2016): 772,245 * Sources: “FDA Approves KEYTRUDA® (Pembrolizumab) plus LENVIMA® (Lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma.” Merck, 17 Sept. 2019, investors.merck.com/news/press-release-details/2019/FDA-Approves-KEYTRUDA-pembrolizumab-plus-LENVIMA- lenvatinib-Combination-Treatment-for-Patients-with-Certain-Types-of-Endometrial-Carcinoma/default.aspx. GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com, Accessed: September 19, 2019. Keytruda (pembrolizumab) [Package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2019. * SEER Cancer Stat Facts: Uterine Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/corp.html. Accessed: September 19, 2019. “Simultaneous Review Decisions for Pembrolizumab plus Lenvatinib in Australia, Canada and US.” U.S. Food & Drug Administration, 17 Sept. 2019, www.fda.gov/drugs/resources-information-approved-drugs/simultaneous-review-decisions-pembrolizumab-plus-lenvatinib-australia-canada-and-us. 2 Drug Information Regulatory Information Manufacturer: Merck Application Type: Supplemental BLA Original Anticipated Approval Drug Brand N/A Keytruda (PDUFA): Name: Regulatory Status: Approved Drug Generic Regulatory Status Date: 7/30/2019 pembrolizumab Name: Regulatory Status Reason: N/A Orphan Drug Designation: 6/15/2017 Drug Type: Monoclonal Antibody FDA Fast Track Designation: N/A Breakthrough Therapy Route of N/A Intravenous Designation Administration: Priority Review Designation: N/A Indication Details Sales Forecast Indication Incidence Incidence Type Squamous Cell U.S. 17,650* Carcinoma of the Esophagus Global 329,762 (ESCC) Source: GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com , Accessed: May 9, 2019. Comments Section On July 30, 2019, FDA approved Keytruda (pembrolizumab) for the treatment of patients with recurrent, locally advanced or metastatic squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10], as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. Esophageal Cancer Prevalence: There were an estimated 46,477 people living with esophageal cancer in the United States in 2016.* Sources: “FDA Approves New Monotherapy Indication for Merck’s KEYTRUDA® (Pembrolizumab).” Merck, 31 July 2019, www.mrknewsroom.com/news- release/prescription-medicine-news/fda-approves-new-monotherapy-indication-mercks-keytruda-pemb. “FDA Approves Pembrolizumab for Advanced Esophageal Squamous Cell Cancer.” U.S. Food and Drug Administration, 31 July 2019, www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-advanced-esophageal-squamous-cell-cancer. GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com , Accessed: July 31, 2019. Keytruda (pembrolizumab) [Package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2019. * SEER Cancer Stat Facts: Esophageal Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/esoph.html. Accessed: July 31, 2019. 3 Drug Information Regulatory Information Manufacturer: Merck Application Type: Supplemental BLA Drug Brand Original Anticipated Approval 6/17/2019 Name: Keytruda (PDUFA): Regulatory Status: Approved Regulatory Status Date: Drug Generic 6/17/2019 pembrolizumab Name: Regulatory Status Reason: N/A Orphan Drug Designation: 10/3/2017 Drug Type: Monoclonal Antibody FDA Fast Track Designation: N/A Route of Breakthrough Therapy N/A Administration: Intravenous Designation Priority Review Designation: 2/20/2019 Indication Details Sales Forecast Indication Prevalence Prevalence Type Small-Cell U.S. 16,845 Lung Cancer Global 278,821 Source: GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com , Accessed: May 9, 2019. Comments Section On February 20, 2019, FDA accepted and granted priority review for a new Supplemental BLA for Keytruda, as monotherapy for the treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy. UPDATE: On June 17, 2019, FDA approved Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Sources: “FDA Approves Pembrolizumab for Metastatic Small Cell Lung Cancer.” U.S. Food and Drug Administration, 18 June 2019, www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-metastatic-small-cell-lung-cancer. “FDA Grants Priority Review to Merck's Supplemental Biologics License Application for KEYTRUDA® (Pembrolizumab) Monotherapy for Third-Line Treatment of Patients with Advanced Small Cell Lung Cancer (SCLC).” Merck - Investors, 20 Feb. 2019, investors.merck.com/news/press-release- details/2019/FDA-Grants-Priority-Review-to-Mercks-Supplemental-Biologics-License-Application-for-KEYTRUDA-pembrolizumab-Monotherapy-for-Third- Line-Treatment-of-Patients-with-Advanced-Small-Cell-Lung-Cancer-SCLC/default.aspx. GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com , Accessed: June 18, 2019. Keytruda (pembrolizumab) [Package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2019. 4 Drug Information Regulatory Information Manufacturer: Merck Application Type: Supplemental BLA Drug Brand Original Anticipated Approval 6/20/2019 Name: Keytruda (PDUFA): Regulatory Status: Approved Regulatory Status Date: Drug Generic 4/19/2019 pembrolizumab Name: Regulatory Status Reason: N/A Orphan Drug Designation: N/A Drug Type: Monoclonal Antibody FDA Fast Track Designation: N/A Route of Breakthrough Therapy 1/9/2018 Administration: Intravenous Designation Priority Review Designation: 2/15/2019 Indication Details Sales Forecast Indication Incidence Incidence Type Metastatic Renal U.S. 10.9 / 100,000 Cell Carcinoma Global > 400,000 Source: GlobalData, Pharma Intelligence Center. https://pharma.globaldata.com , Accessed: May 9, 2019. Comments Section On April 19, 2019, FDA approved Keytruda (pembrolizumab) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Renal Cell Carcinoma Prevalence (U.S., 2019): 248,722 Renal Cell Carcinoma Prevalence (Global, 2019): 997,049 It is estimated that up to 30% of patients with renal cell carcinoma have metastatic disease at the time of diagnosis. Sources: Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68:394-424. https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21492. “FDA Approves Pembrolizumab plus Axitinib for Advanced Renal Cell Carcinoma.”
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