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          Withdrawn | Cancer Accelerated Approvals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 approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin lymphomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin 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 a quick update on a recent FDA cancer drug approval.

On November 10, 2022, the FDA approved brentuximab vedotin brand name Adcetris in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.

Efficacy was evaluated in a randomized, open-label, actively controlled trial. High risk was identified as Ann Arbor Stage IIB with bulk disease, Stage IIIB, Stage IVA, and Stage IVB. Of the 600 total patients randomized, 300 were randomized to brentuximab vedotin plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide, and 300 patients were randomized to doxorubicin plus bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. The main efficacy outcome measure was event-free survival, defined as the time from randomization to the earliest of disease progression or relapse, second malignancy, or death due to any cause. Median event-free survival was not reached in either arm. There were 23 events in the brentuximab vedotin arm and 52 events in the control arm with a corresponding hazard ratio of 0.41.

The most common Grade 3 or greater adverse reactions occurring in more than 5% of pediatric patients treated with brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for these approvals can be found on the web at Drugs@FDA: FDA-Approved Drugs.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

                                                                                  Content current as of:
      12/15/2022Resources 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