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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
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        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: Approval of Opdivo (nivolumab) for resected esophageal or gastroesophageal junction cancer with residual disease who have received chemoradiotherapy and Rybrevant (amivantamab-vmjw) for locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutationsResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: Approval of Opdivo (nivolumab) for resected esophageal or gastroesophageal junction cancer with residual disease who have received chemoradiotherapy and Rybrevant (amivantamab-vmjw) for locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
  
  	
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Welcome 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 2 recent FDA cancer drug approvals.

On May 20, 2021, FDA approved nivolumab (brand name Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

Efficacy was evaluated in CHECKMATE-577, a randomized, multicenter, double-blind trial in 794 patients with completely resected esophageal or gastroesophageal junction cancers who had residual pathologic disease following concurrent chemoradiotherapy. Patients were randomized 2:1 to receive either nivolumab or placebo every 2 weeks for 16 weeks followed by nivolumab or placebo every 4 weeks beginning at week 17 for up to one year of treatment.

The main efficacy outcome measure was disease-free survival, defined as the time between randomization date and the first recurrence date, or death, from any cause, as assessed by an investigator prior to subsequent anti-cancer therapy.

CHECKMATE-577 demonstrated a statistically significant improvement in disease-free survival for patients receiving nivolumab as compared to those on the placebo arm. The median disease-free survival was 22.4 months versus 11 months, respectively. The disease-free survival benefit was observed regardless of tumor PD-L1 expression and histology.

The most common adverse reactions reported in more than 20%of patients receiving nivolumab were fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting.

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 also 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 May 21, 2021, FDA granted accelerated approval to amivantamab-vmjw (brand name Rybrevant), a bispecific antibody directed against epidermal growth factor and MET receptors, for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

FDA also approved the Guardant360® CDx as a companion diagnostic for amivantamab-vmjw.

Approval was based on CHRYSALIS, a multicenter, non-randomized, open label, multicohort clinical trial which included patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations. Efficacy was evaluated in 81 patients with advanced non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. Patients received amivantamab-vmjw once weekly for 4 weeks, then every 2 weeks thereafter until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate according to RECIST 1.1 as evaluated by blinded independent central review and response duration. The overall response rate was 40% with a median response duration of 11.1 months.

The most common adverse reactions reported in more than 20% of patients were rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting.

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 also 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 on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting System 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 in to the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      06/08/2021Resources 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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