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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: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinomaResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for patients with mismatch repair deficient recurrent or advanced solid tumors, and Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial 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’ll provide a quick update on two recent FDA cancer drug approvals.

On August 17, 2021, the FDA approved dostarlimab-gxly (brand name Jemperli) for adult patients with mismatch repair deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

The FDA also approved the VENTANA MMR RxDx Panel as a companion diagnostic device to select patients with mismatch repair deficient solid tumors for treatment with dostarlimab-gxly.

The efficacy of dostarlimab was evaluated in the GARNET Trial, a non-randomized, multicenter, open-label, multi-cohort trial. The efficacy population consisted of 209 patients with mismatch repair deficient recurrent or advanced solid tumors who progressed following systemic therapy and had no satisfactory alternative treatment.

The primary efficacy endpoints were overall response rate and duration of response as determined by blinded independent central review according to RECIST 1.1. The overall response rate was 41.6%, with 9.1% complete response rate and 32.5% partial response rate. Median duration of response was 34.7 months, with 95.4% of patients with duration greater than or equal to 6 months. Most common adverse reactions reported in more than 20% of patients with mismatch repair deficient solid tumors were fatigue /asthenia, anemia, diarrhea, and nausea. Immune-mediated adverse reactions are also associated with dostarlimab-gxly including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and dermatologic toxicity.

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

On August 19, 2021, the FDA approved nivolumab (brand name Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection. This is the first FDA approval for adjuvant treatment of patients with high-risk urothelial carcinoma.

Nivolumab was investigated in CHECKMATE-274, a randomized, double-blind, placebo-controlled trial in patients who were within 120 days of radical resection of urothelial carcinoma of the bladder or upper urinary tract (renal pelvis or ureter) at high risk of recurrence. Patients were randomized (1:1) to receive nivolumab or placebo by intravenous infusion every 2 weeks until recurrence or until unacceptable toxicity for a maximum treatment duration of 1 year.

The primary efficacy endpoint was investigator-assessed disease-free survival in the intent-to-treat population and in patients with tumors expressing PD-L1 greater than or equal to 1%. Disease-free survival was defined as time -to- first recurrence (local urothelial tract, local non-urothelial tract, or distant metastasis), or death. At a prespecified interim analysis, a statistically significant improvement in disease-free survival was demonstrated in patients on the nivolumab arm vs. placebo for both primary endpoints. In the intent-to-treat analysis, the median disease-free survival was 20.8 months in patients who received nivolumab compared with 10.8 months in patients who received placebo. For patients with tumors expressing PD-L1 greater than or equal to 1%, median disease-free survival was not reached in those who received nivolumab vs. 8.4 months for patients who received placebo.

In an exploratory analysis of patients with 58% PD-L1-negative tumors, the unstratified disease-free survival hazard ratio estimate was 0.83. Overall survival data is immature with 33% of deaths in the overall randomized population. In the upper tract urothelial carcinoma subpopulation, 37 deaths occurred (20 in the nivolumab arm, 17 in the placebo arm).

The most common adverse reactions reported in more than 20% of patients who received nivolumab in CHECKMATE-274 were rash, fatigue, diarrhea, pruritus, musculoskeletal pain, and urinary tract infection.

This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, as well as the Assessment Aid and the Product Quality Assessment Aid, voluntary submissions from the applicant to facilitate the FDA’s assessment.

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 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. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      08/30/2021Resources 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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