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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          Withdrawn | Cancer Accelerated Approvals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


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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with 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: FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
  
  	
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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 September 14, 2021, the FDA granted accelerated approval to zanubrutinib (brand name Brukinsa) for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen.

Approval is based on two open-label, multicenter, single-arm trials. BGB-3111-214 evaluated 66 patients with marginal zone lymphoma who received at least one prior anti-CD20-based therapy. And BGB-3111-AU-003 included 20 patients with previously treated marginal zone lymphoma. The efficacy measures were overall response rate and duration of response, as assessed by an independent review committee using the 2014 Lugano criteria. In the first trial, the CT-based overall response rate was 56%, with 20% achieving complete responses. In the second trial, the overall response rate was 80%, with a complete response rate of 20%. The median duration of response was not estimable; the estimated 1-year rate of duration of response was 85% and 72%, respectively.

The most common adverse reactions to zanubrutinib reported in more than 30% of patients included decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash, and musculoskeletal pain. Serious adverse reactions occurred in 40% of patients with marginal zone lymphoma, most often from pyrexia and pneumonia. The prescribing information includes warnings and precautions for hemorrhage, infections, cytopenias, second primary malignancies, and cardiac arrythmias.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

On September 15, 2021, the FDA granted accelerated approval to mobocertinib (brand name Exkivity) 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.

Today, the FDA also approved the Oncomine Dx Target Test as a companion diagnostic device to select patients with the above mutations for mobocertinib treatment.

Approval was based on Study 101, an international, 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 114 patients whose disease had progressed on or after platinum-based chemotherapy.

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 28% with a median response duration of 17.5 months.

The most common adverse reactions reported in more than 20% of patients were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain. Product labeling includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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.

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:
      09/28/2021Resources 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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