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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
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                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki)  for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki)  for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate 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 two recent FDA cancer drug approvals. On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand name Enhertu) for adult patients with unresectable or metastatic HER2-low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Efficacy was based on DESTINY-Breast04, a randomized, multicenter, open-label clinical trial that enrolled 557 patients with unresectable or metastatic HER2-low breast cancer. The trial included two cohorts: 494 hormone receptor-positive (or HR+) patients and 63 hormone receptor-negative (or HR-negative) patients. HER2-low expression was defined as IHC 1+ or IHC 2+/ISH-, determined at a central laboratory. Patients were randomized 2:1 to receive either Enhertu 5.4 mg/kg by intravenous infusion every 3 weeks or physician’s chemotherapy choice.

The primary efficacy measure was progression-free survival in patients with HR+ breast cancer, assessed by blinded independent central review using RECIST 1.1. Secondary efficacy measures were progression-free survival in the overall population, overall survival in HR+ patients, and overall survival in the overall population.

The median age of patients was 57 years and 24% were 65 or older. Selected demographics were reported as follows: 99.6% female, 48% White, 40% Asian, 2% Black or African American, 3.8% Hispanic/Latino. Median progression-free survival in the HR+ cohort was 10.1 months in the Enhertu arm and 5.4 months in the chemotherapy arm. Median progression-free survival in the overall population was 9.9 months in the Enhertu arm and 5.1 months in those receiving chemotherapy.

In the HR+ cohort, median overall survival was 23.9 months and 17.5 months in the Enhertu and chemotherapy arms, respectively. In the overall population, median overall survival was 23.4 months in the Enhertu arm versus 16.8 months in the chemotherapy arm.

The prescribing information includes a Boxed Warning advising health professionals of the risk of interstitial lung disease and embryo-fetal toxicity.

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 program, which streamlined data submission prior to the filing of the complete clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application approximately four months ahead of the FDA goal date.

On August 5, 2022, the FDA also approved darolutamide (brand name Nubeqa) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.

Efficacy was based on ARASENS, a randomized, multicenter, double-blind, placebo-controlled clinical trial in 1306 patients with metastatic hormone-sensitive prostate cancer. Patients were randomized to receive either darolutamide 600 mg orally twice daily plus docetaxel 75 mg/m2 intravenously administered every 3 weeks for up to 6 cycles or docetaxel plus placebo. All patients received a gonadotropin-releasing hormone analog concurrently or had a bilateral orchiectomy.

The primary efficacy measure was overall survival. Time-to-pain progression was an additional efficacy measure. Median overall survival was not reached in the darolutamide plus docetaxel arm and 48.9 months in the docetaxel plus placebo arm. Treatment with darolutamide and docetaxel resulted in a statistically significant delay in time-to-pain progression.

The median age of patients was 67 years and 17% were 75 years or older. Selected demographics were reported as follows: 52% White, 36% Asian, 4% Black or African American, 7% Hispanic/Latino. Three percent of patients had M1a disease, 83% had M1b, and 14% had M1c.

The most common adverse reactions experienced in more than 10% of patients were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities occurring in more than 30% were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia.

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. The FDA approved this application approximately one 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:
      09/07/2022Resources 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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