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          Withdrawn | Cancer Accelerated Approvals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 Jemperli (dostarlimab-gxly) for adults with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-lpyl) for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapyResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for adults with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-lpyl) for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
  
  	
    Share
    Post
    Linkedin

    Email
    PrintPodcast

Welcome 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 have another update on two recent FDA cancer drug approvals.

On April 22, 2021, FDA granted accelerated approval to dostarlimab-gxly (brand name Jemperli) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.

Efficacy was evaluated based on cohort A1 in the GARNET Trial, a multicenter, multicohort, open-label trial in patients with advanced solid tumors. The efficacy population consisted of 71 patients with mismatch repair deficient recurrent or advanced endometrial cancer who progressed on or after a platinum-containing regimen.

The main efficacy endpoints were overall response rate and duration of response, as assessed by blinded independent central review according to RECIST 1.1. Confirmed overall response rate was 42.3%. The complete response rate was 12.7% and partial response rate was 29.6%. Median duration of response was not reached, with 93.3% of patients having durations longer than 6 months.

Serious adverse reactions reported in more than 2% of patients included sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia. The most common adverse reactions reported in more than 20% of patients were fatigue/asthenia, nausea, diarrhea, anemia, and constipation. The most common grade 3 or 4 adverse reactions occurring in more than 2% of patients were anemia and increase in transaminases. Immune-mediated adverse reactions can occur including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic device for selecting endometrial cancer patients for treatment with dostarlimab-gxly.

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.

On April 23, 2021, FDA granted accelerated approval to loncastuximab tesirine-lpyl (brand name Zynlonta), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma arising from low grade lymphoma, and high-grade B-cell lymphoma.

Approval was based on LOTIS-2, an open-label, single-arm trial in 145 adult patients with relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma after at least two prior systemic regimens. Patients received treatment until progressive disease or unacceptable toxicity.

The main efficacy outcome measure was overall response rate, as assessed by an independent review committee using Lugano 2014 criteria. The overall response rate was 48.3% with a complete response rate of 24.1%. After a median follow-up of 7.3 months, median response duration was 10.3 months. Of the 70 patients who achieved objective responses, 36% were censored for response duration prior to 3 months.

The prescribing information provides warnings and precautions for adverse reactions including edema and effusions, myelosuppression, infections, and cutaneous reactions.

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 System at MedWatch.

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

                                                                                  Content current as of:
      04/29/2021Resources 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