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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast 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 March 3, 2023, the FDA approved abemaciclib (brand name Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence.

Patients defined as high risk included those having either greater than or equal to 4 pathologic axillary lymph nodes or 1-3 pathologic axillary lymph nodes and either tumor grade 3 or a tumor size greater than or equal to 50 mm.

Abemaciclib was previously approved for the above high-risk population with the additional requirement of having a Ki-67 score of greater than or equal to 20%. Today’s approval removes the Ki-67 testing requirement.

Efficacy was evaluated in monarchE, a randomized 1:1, open-label, two-cohort multicenter trial including adult women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, resected, early breast cancer with clinical and pathological features consistent with a high risk of recurrence. To be enrolled in cohort 1, patients must have had either greater than or equal to 4 pathologic axillary lymph nodes or 1-3 pathologic axillary lymph nodes and either tumor grade 3 or a tumor size greater than or equal to 50 mm. To be enrolled in cohort 2, patients could not be eligible for cohort 1 and must have had 1-3 pathologic axillary lymph nodes and tumor Ki-67 score of greater than or equal to 20%. Patients were randomized to either 2 years of abemaciclib plus physician’s choice of standard endocrine therapy or standard endocrine therapy alone.

The major efficacy outcome measure was invasive disease-free survival. A statistically significant difference was observed in the intent-to-treat population, primarily attributed to the patients in cohort 1. Invasive disease-free survival at 48 months was 85.5% for abemaciclib plus standard endocrine therapy and 78.6% for standard endocrine therapy alone. Overall survival data remains immature, however, in cohort 2, more deaths were observed with abemaciclib plus standard endocrine therapy compared to standard endocrine therapy alone. Therefore, the indication was restricted to cohort 1.

The most common adverse reactions occurring in more than 20% of patients were diarrhea, infections, neutropenia, fatigue, leukopenia, nausea, anemia, and headache.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 2 months 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:
      03/24/2023Resources 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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