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                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
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          Other | Cancer Accelerated Approvals


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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O Burst Edition: FDA approvals of Opdivo (nivolumab) for early-stage non-small cell lung cancer and Lynparza (olaparib) for the adjuvant treatment of high-risk early breast cancerResources for Information | Approved Drugs FDA D.I.S.C.O Burst Edition: FDA approvals of Opdivo (nivolumab) for early-stage non-small cell lung cancer and Lynparza (olaparib) for the adjuvant treatment of high-risk 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 two recent FDA cancer drug approvals.

On March 4, 2022, the FDA approved nivolumab (brand name Opdivo) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.

This represents the first FDA approval for neoadjuvant therapy for early-stage non-small cell lung cancer.

Efficacy was evaluated in CHECKMATE-816, a randomized, open label trial in patients with resectable, histologically confirmed Stage IB, II, or IIIA non-small cell lung cancer and measurable disease. Patients were enrolled regardless of the tumor PD-L1 status. A total of 358 patients were randomized to receive either nivolumab plus platinum-doublet chemotherapy administered every 3 weeks for up to 3 cycles, or platinum-chemotherapy alone administered on the same schedule.

The main efficacy outcome measures were event-free survival and pathologic complete response by blinded independent central review. Median event-free survival was 31.6 months in the nivolumab plus chemotherapy arm and 20.8 months for those receiving chemotherapy alone. The hazard ratio was 0.63. The pathologic complete response rate was 24% in the nivolumab plus chemotherapy arm and 2.2% in the chemotherapy alone arm.

The most common adverse reactions occurring in more than 20% of patients were nausea, constipation, fatigue, decreased appetite, and rash. The addition of nivolumab to chemotherapy did not result in more frequent delays or cancellations of surgery. The median lengths of hospital stays following definitive surgery and the rates of adverse reactions identified as surgical complications were similar for patients in both arms of the trial.

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 five months ahead of the FDA goal date.

On March 11, 2022, the FDA approved olaparib (brand name Lynparza) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated human epidermal growth factor receptor 2 (or HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Approval was based on OlympiA, a randomized 1:1, double-blind, placebo-controlled, international study of 1836 patients with germline BRCA-mutated HER2-negative high-risk early breast cancer who completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. Patients were required to have completed at least 6 cycles of neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes, or both. Patients with hormone receptor positive breast cancer were allowed to continue concurrent treatment with endocrine therapy per local guidelines.

The primary efficacy endpoint was invasive disease-free survival, defined as the time from randomization to date of first recurrence defined as invasive loco-regional, distant recurrence, contralateral invasive breast cancer, new cancer, or death from any cause. For invasive disease-free survival, there were 106 events in the olaparib arm and 178 events in the placebo arm. Invasive disease-free survival at 3 years was 86% for patients receiving olaparib and 77% for those receiving placebo. An additional efficacy endpoint was overall survival. There were 75 deaths in the olaparib arm and 109 deaths in the placebo arm. A statistically significant improvement in invasive disease-free survival and overall survival was demonstrated in patients in the Lynparza arm compared with the placebo arm.

The most common adverse reactions occurring in more than 10% of patients in the OlympiA study were nausea, fatigue (including asthenia), anemia, vomiting, headache, diarrhea, leukopenia, neutropenia, decreased appetite, dysgeusia, dizziness and stomatitis.

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.govFDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      04/06/2022Resources 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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