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          Withdrawn | Cancer Accelerated Approvals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 Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for patients with unresectable locally advanced or metastatic triple negative breast cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Erbitux (cetuximab) for K-Ras wild type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck and Trodelvy (sacituzumab govitecan) for patients with unresectable locally advanced or metastatic triple negative breast cancer
  
  	
    Share
    Post
    Linkedin

    Email
    PrintPodcast

Welcome to the DISCO, 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 an update on two recent FDA cancer drug approvals.

On April 6, 2021, FDA approved a new dosage regimen of 500 mg/m2 as a 120 minute intravenous infusion every two weeks for cetuximab (brand name Erbitux) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

This approval provides for a biweekly dosage regimen option in addition to the previously approved weekly dosage regimen for the approved indications when cetuximab is used as a single agent or in combination with chemotherapy.

The approval was based on population PK modeling analyses that compared the predicted exposures of cetuximab 500 mg every two weeks, to observed cetuximab exposures in patients who received 250 mg weekly. The application was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival from published literature in patients with colorectal cancer and squamous cell carcinoma of the head and neck, and overall survival analyses using real-world data in patients with EGFR-expressing colorectal cancer who received either the weekly cetuximab or every two weeks regimen. In these exploratory analyses, the observed efficacy results were consistent across dosage regimens and supported the results of the population PK modeling analyses.

The most common adverse reactions to cetuximab, reported in more than 25% of patients were cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection.

The FDA approved this application approximately 5 months ahead of the FDA goal date.

On April 7, 2021, FDA approved sacituzumab govitecan (brand name Trodelvy) for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one for metastatic disease.

Efficacy and safety were evaluated in ASCENT, a multicenter, open-label, randomized trial conducted in 529 patients with unresectable locally advanced or metastatic triple-negative breast cancer who had relapsed after at least two prior chemotherapies, one of which could be in the neoadjuvant or adjuvant setting if progression occurred within 12 months. Patients were randomized 1:1 to receive sacituzumab govitecan, or physician’s choice of single agent chemotherapy.

The primary efficacy endpoint was progression-free survival in patients without brain metastases at baseline as measured by a blinded, independent, centralized review assessed using RECIST 1.1 criteria. Additional efficacy endpoints included progression-free survival for the full population with and without brain metastases and overall survival.

Among all randomized patients, median progression-free survival for patients receiving sacituzumab govitecan was 4.8 months compared with 1.7 months in those receiving chemotherapy. Median overall survival was 11.8 months and 6.9 months respectively.

This trial was the confirmatory trial for the April 2020 accelerated approval for patients with metastatic triple-negative breast cancer.

Most common adverse reactions reported in more than 25% of patients receiving sacituzumab govitecan were nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain.

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 review also 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. The FDA approved this application 6 weeks ahead of the FDA goal date.

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

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting System 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 into this D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      04/16/2021Resources 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