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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutationResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation
  
  	
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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 16, 2023, the FDA approved dabrafenib (brand name Tafinlar) with trametinib (brand name Mekinist) for pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills.

This represents the first FDA approval of a systemic therapy for the first-line treatment of pediatric patients with low-grade glioma with a BRAF V600E mutation.

Efficacy was evaluated in Study CDRB436G2201, a multicenter, open-label trial in patients with low-grade glioma requiring first systemic therapy. Patients were randomized 2:1 to dabrafenib plus trametinib or carboplatin plus vincristine. BRAF mutation status was identified prospectively by local or central laboratory tests. Retrospective testing of available tumor samples by the central laboratory was also performed to evaluate mutation status. Patients received age- and weight-based dosing of dabrafenib plus trametinib until they were no longer deriving benefit or experienced unacceptable toxicity. Carboplatin plus vincristine were dosed based on body surface area at 175 mg/m2 and 1.5 mg/m2, respectively, as one 10-week induction course, followed by eight 6-week cycles of maintenance therapy.

The major efficacy outcome measure was overall response rate by independent review based on RANO LGG (2017) criteria. Additional efficacy outcome measures were progression- free survival and overall survival. The primary analysis was performed when all patients had completed at least 32 weeks of therapy.

In the pooled safety population of pediatric patients receiving dabrafenib plus trametinib, the most common adverse reactions occurring in more than 20% of patients were pyrexia, rash, headache, vomiting, musculoskeletal pain, fatigue, dry skin, diarrhea, nausea, epistaxis and other bleeding events, abdominal pain, and dermatitis acneiform. The most common Grade 3 or 4 laboratory abnormalities occurring in more than 2% were decreased neutrophil count, increased alanine aminotransferase, and aspartate aminotransferase increased.

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

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:
      04/06/2023Resources 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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