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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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          FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor (or an HHI) is not appropriateResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor (or an HHI) is not appropriate
  
  	
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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 another recent FDA cancer drug approval.

On February 9, 2021, the FDA approved cemiplimab-rwlc (brand name Libtayo) for patients with locally advanced or metastatic basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor (or an HHI) is not appropriate.

Efficacy was evaluated in Study 1620, an ongoing open-label, multi-center, non-randomized trial in patients with locally advanced or metastatic basal cell carcinoma who had progressed on, were unresponsive to, or intolerant of HHI therapy. Per multidisciplinary assessment, eligibility required that locally advanced basal cell carcinoma patients were not candidates for curative surgery or curative radiation therapy.

The main efficacy outcome measures were confirmed objective response rate and duration of response as assessed by independent central review. For patients with metastatic basal cell carcinoma without externally visible target lesions, confirmed objective response rate was assessed according to RECIST 1.1. A composite response assessment incorporating clinical response criteria using digital medical photography together with RECIST 1.1, was used for those patients with locally advanced basal cell carcinoma and metastatic basal cell carcinoma. with externally visible target lesions.

Among 84 patients with locally advanced basal cell carcinoma, the confirmed objective response rate was 29% with a median duration of response not reached and 79% of responders maintaining their response for at least 6 months. Among 28 patients with metastatic basal cell carcinoma, the confirmed objective response rate was 21% with a median duration of response not reached, and all responders maintaining their responses for at least 6 months.

Severe adverse reactions are immune-mediated adverse reactions such as pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus and nephritis, and infusion reactions. The most common adverse reactions occurring in more than 20% of patients were fatigue, musculoskeletal pain, diarrhea, rash, and pruritis.

FDA used the accelerated approval pathway for the metastatic basal cell carcinoma indication. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

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 into the DISCO Burst Edition.

                                                                                  Content current as of:
      03/09/2021Resources 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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