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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 Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumorResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Xalkori (crizotinib) for ALK-positive inflammatory myofibroblastic tumor
  
  	
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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 July 14, 2022, the FDA approved crizotinib (brand name Xalkori) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase-positive myofibroblastic tumors. The safety and efficacy of crizotinib were evaluated in two multicenter, single-arm, open-label trials that included 14 pediatric patients from trial ADVL0912 and 7 adult patients from trial A8081013 with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase -positive myofibroblastic tumors.

The major efficacy outcome measure of these trials was objective response rate. For the 14 pediatric patients, a total of 12 of the 14 patients experienced an objective response, assessed by an independent review committee. For the 7 adult patients, 5 patients had objective responses.

The most common adverse reactions occurring in more than 35% of pediatric patients were vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. The most frequent adverse reactions occurring in more than 35% of adult patients were vision disorders, nausea, and edema.

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:
      08/01/2022Resources 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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