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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer
  
  	
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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 September 2, 2022, FDA approved durvalumab (brand name Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.

Efficacy was evaluated in TOPAZ-1, a randomized, double-blind, placebo-controlled, multiregional trial that enrolled 685 patients with histologically confirmed locally advanced unresectable or metastatic biliary tract cancer who had not previously received systemic therapy for advanced disease.

Trial demographics were as follows: 56% Asian, 37% White, 2% Black, and 4% other race; 7% Hispanic or Latino; 50% male and 50% female; median age was 64 years, ranging from 20-85, and 47% were 65 years or older. Fifty-six percent had intrahepatic cholangiocarcinoma, 25% had gallbladder cancer, and 19% had extrahepatic cholangiocarcinoma.

The major efficacy outcome measure was overall survival. Tumor assessments were conducted every 6 weeks for the first 24 weeks, then every 8 weeks until confirmed objective disease progression. A statistically significant improvement in overall survival was demonstrated in patients randomized to receive durvalumab with gemcitabine and cisplatin compared to those randomized to receive placebo with gemcitabine and cisplatin. Median overall survival was 12.8 months and 11.5 months in the durvalumab and placebo arms, respectively. The median progression-free survival was 7.2 months and 5.7 months in the durvalumab and placebo arms, respectively. Investigator-assessed overall response rate was 27% and 19% in the durvalumab and placebo arms, respectively.

The most common adverse reactions occurring in more than 20% of patients were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia. 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 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 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 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 via email to FDAOncology@fda.hhs.gov.

                                                                                  Content current as of:
      10/17/2022Resources 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
 
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