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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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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic solid tumors with BRAF V600E mutationResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic solid tumors with 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 another quick update on a recent FDA cancer drug approval. On June 22, 2022, the FDA granted accelerated approval to dabrafenib (brand name Tafinlar) in combination with trametinib (brand name Mekinist) for treatment of adult and pediatric patients 6 years of age or older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors.

The safety and efficacy were evaluated in 131 adult patients from open-label, multiple cohort trials BRF117019 and NCI-MATCH, 36 pediatric patients from CTMT212X2101, and supported by results in COMBI-d, COMBI-v, and BRF113928 (studies in melanoma and lung cancer already described in product labeling). Study BRF117019 enrolled patients with BRAF V600E mutation positive specific solid tumors including high grade glioma, biliary tract cancer, low grade glioma, adenocarcinoma of small intestine, gastrointestinal stromal tumor, and anaplastic thyroid cancer. NCI-MATCH Subprotocol H enrolled adult patients with BRAF V600E mutation positive solid tumors except patients with melanoma, thyroid cancer, or CRC. Parts C and D of Study CTMT212X2101 enrolled 36 pediatric patients with BRAF V600 refractory or recurrent LGG or HGG. The major efficacy outcome measure of these studies was overall response rate using standard response criteria. For the 131 adult patients, a total of 54 experienced an objective response. The studies enrolled patients with 24 tumor types, including different subtypes of low grade glioma and high grade glioma. Among the highest representative tumor types, overall response rate was 46% for biliary tract cancer, 33% for high grade glioma (combined) and 50% for low grade glioma (combined). For the 36 pediatric patients, the overall response rate was 25%; duration of response was 6 months or greater for 78% of patients and 24 months or greater for 44% of patients.

The most common adverse reactions occurring in more than 20% of adult patients were pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.

The most common adverse reactions occurring in more than 20% of pediatric patients were pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia.

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

                                                                                  Content current as of:
      07/25/2022Resources 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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