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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 Verzenio (abemaciclib) for adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer, & Keytruda (pembrolizumab) for persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1)Resources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Verzenio (abemaciclib) for adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer, & Keytruda (pembrolizumab) for persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1)
  
  	
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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 October 12, 2021, the FDA approved abemaciclib (brand name Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibitor) for 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 and a Ki-67 score of 20% or higher, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.

FDA also approved the Ki-67 IHC MIB-1 pharmDx assay as a companion diagnostic for selecting patients for this indication.

Efficacy was evaluated in monarchE, a randomized 1:1, open-label, two-cohort multicenter trial that included 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 disease recurrence. Patients were randomized to receive either 2 years of abemaciclib plus their physician’s choice of standard endocrine therapy or standard endocrine therapy alone.

The major efficacy outcome measure was invasive disease-free survival. In patients with high risk of recurrence and Ki-67 Score of 20% or higher, the trial demonstrated a statistically significant improvement in invasive disease-free survival. Invasive disease-free survival at 36 months was 86.1% for patients receiving abemaciclib plus tamoxifen or an aromatase inhibitor and 79.0% for those receiving tamoxifen or an aromatase inhibitor. Overall survival data were not mature at the time of the invasive disease-free survival analysis.

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

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 October 13, 2021, the FDA approved pembrolizumab (brand name Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.

FDA also granted regular approval to pembrolizumab as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. In June 2018, FDA had granted accelerated approval to this indication with the companion diagnostic, PD-L1 IHC 22C3 pharmDx.

KEYNOTE-826, a multicenter, randomized, double-blind, placebo-controlled trial, examined pembrolizumab with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab. The trial enrolled 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not been treated with chemotherapy. Patients were enrolled irrespective of PD-L1 expression status. Patients were randomized 1:1 to one of two treatment groups: pembrolizumab 200 mg plus chemotherapy with or without bevacizumab or placebo plus chemotherapy with or without bevacizumab. Pembrolizumab was continued until disease progression, unacceptable toxicity, or 24 months of treatment.

The main efficacy outcome measures were overall survival and progression-free survival assessed by the investigator using RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Additional outcome measures were objective response rates and duration of response. For patients with tumors expressing PD-L1, the median overall survival was not reached in the pembrolizumab arm and was 16.3 months in the placebo arm. Median progression-free survival was 10.4 months in the pembrolizumab arm and 8.2 months in the placebo arm. The objective response rates were 68% and 50% with median duration of response of 18.0 and 10.4 months in the pembrolizumab and placebo arms, respectively.

The most common adverse reactions reported in more than 20% of patients treated with pembrolizumab, chemotherapy, and bevacizumab were peripheral neuropathy, alopecia, anemia, fatigue/asthenia, nausea, neutropenia, diarrhea, hypertension, thrombocytopenia, constipation, arthralgia, vomiting, urinary tract infection, rash, leukopenia, hypothyroidism, and decreased appetite.

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 are ongoing at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 4 months ahead of the FDA goal date.

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. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      10/25/2021Resources 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
 
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