Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
          Drugs
          Development & Approval Process | Drugs
          Drug Approvals and Databases
          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Opdivo in combination with chemotherapy and Opdivo in combination with Yervoy for first-line advanced or metastatic esophageal squamous cell carcinoma, and Kymriah (tisagenlecleucel) for relapsed or refractory follicular lymphoma
  
  	
    Share
    Post
    Linkedin

    Email
    PrintPodcast

Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on two recent FDA cancer drug approvals. On May 27, 2022, the FDA approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma:

nivolumab (brand name Opdivo) in combination with fluoropyrimidine- and platinum-based chemotherapy
	nivolumab in combination with ipilimumab (brand name Yervoy)Efficacy was evaluated in CHECKMATE-648, a randomized, active-controlled, open-label trial in 970 patients with previously untreated unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. Prior treatment with curative intent was allowed if completed more than six months before trial enrollment. The trial excluded patients with brain metastasis that were symptomatic, active autoimmune disease, receiving systemic corticosteroids or immunosuppressants, or patients at high risk of bleeding or fistula due to apparent invasion of tumor to organs adjacent to the esophageal tumor. The major efficacy outcome measures were overall survival and blinded independent central review-assessed progression-free survival. CHECKMATE-648 demonstrated statistically significant improvements in overall survival in all randomized patients and in the subpopulation with tumor cell PD-L1 greater than or equal to 1% for both nivolumab-containing regimens when individually compared to chemotherapy.

In the ITT population overall survival results revealed:

The hazard ratio of the comparison nivolumab, fluorouracil, and cisplatin vs. chemotherapy was 0.74.
	The hazard ratio of the comparison of nivolumab and ipilimumab vs. chemotherapy was 0.78.In the ITT population, the median overall survival was 13.2 months in the nivolumab, fluorouracil, and cisplatin arm, 12.8 months in the nivolumab and ipilimumab arm, and 10.7 months in the fluorouracil and cisplatin arm.

In the tumor cell PD-L1 greater than 1% population overall survival results revealed:

The hazard ratio for the comparison nivolumab, fluorouracil, and cisplatin vs. chemotherapy alone was 0.54.
	The hazard ratio of the comparison of nivolumab and ipilimumab vs. chemotherapy was 0.64.The most common adverse reactions occurring in more than 20% of patients treated with nivolumab and fluoropyrimidine- and platinum-containing chemotherapy in CHECKMATE-648 were nausea, decreased appetite, fatigue, constipation, stomatitis, diarrhea, and vomiting. The most common adverse reactions occurring in more than 20% of patients treated with nivolumab and ipilimumab in CHECKMATE-648 were rash, fatigue, pyrexia, nausea, diarrhea, and constipation.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews may be ongoing at the other regulatory agencies.

This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Also on May 27, 2022, the FDA granted accelerated approval to tisagenlecleucel (brand name Kymriah) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

The approval was based on the ELARA trial, a multicenter, single-arm, open-label trial evaluating tisagenlecleucel, a CD19-directed chimeric antigen receptor T cell therapy, in adult patients who were refractory or relapsed within 6 months after completion of two or more lines of systemic therapy or relapsed after autologous hematopoietic stem cell transplant.

The main efficacy measures were overall response rate and duration of response as determined by an independent review committee. Among 90 patients in the primary efficacy analysis, the overall response rate was 86% with a complete response rate of 68%. The median duration of response was not reached, with 75% of responders still in response at 9 months. For all patients who underwent leukapheresis, the overall response rate was 86% with a complete response rate of 67%.

The most common adverse reactions occurring in more than 20% of patients were cytokine release syndrome, infection, fatigue, musculoskeletal pain, headache, and diarrhea.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 1 month ahead of the FDA goal date.

Full prescribing information for these approvals can be found at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback to FDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      06/23/2022Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop