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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 Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for advanced endometrial carcinoma
  
  	
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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 have a quick update on another recent FDA cancer drug approval.

On July 21, 2021, the FDA approved pembrolizumab (brand name Keytruda) in combination with lenvatinib (brand name Lenvima) for patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

FDA granted accelerated approval on September 17, 2019 to pembrolizumab with lenvatinib for advanced endometrial carcinoma. Study 309 - KEYNOTE-775 was a multicenter, open-label, randomized, active-controlled trial required to confirm the clinical benefit of this accelerated approval.

The trial enrolled 827 patients with advanced endometrial carcinoma previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including neoadjuvant and adjuvant treatments. Patients were randomized 1:1 to either pembrolizumab with lenvatinib or investigator’s choice of doxorubicin or paclitaxel.

The major efficacy outcome measures were progression-free survival, as assessed by blinded independent central review, and overall survival. Additional efficacy outcome measures included objective response rate and duration of response, also blinded independent central review-assessed.

For patients with advanced endometrial cancer that is not microsatellite instability-high or mismatch repair deficient, the median progression-free survival was 6.6 months for patients in the pembrolizumab and lenvatinib group and 3.8 months for those receiving investigator’s choice chemotherapy. Median overall survival was 17.4 months and 12 months, respectively. Objective response rate was 30% and 15%, respectively. Median duration of response was 9.2 months and 5.7 months.

The most common adverse reactions reported in more than 20% of patients in trials of pembrolizumab in combination with lenvatinib were hypothyroidism, hypertension, fatigue, diarrhea, musculoskeletal disorders, nausea, decreased appetite, vomiting, stomatitis, weight loss, abdominal pain, urinary tract infection, proteinuria, constipation, headache, hemorrhagic events, palmar-plantar erythrodysesthesia, dysphonia and rash.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 6 weeks prior to the FDA goal date.

Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatfda.

Healthcare 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. And thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      07/30/2021Resources 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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