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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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                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Home
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          Resources for Information | Approved Drugs
          FDA D.I.S.C.O.: Burst Edition: FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapyResources for Information | Approved Drugs FDA D.I.S.C.O.: Burst Edition: FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy
  
  	
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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 a recent FDA cancer drug approval.

On March 23, 2022, the FDA approved Pluvicto (active ingredient lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.

On the same day, the FDA approved Locametz (active ingredient gallium Ga 68 gozetotide), a radioactive diagnostic agent for positron emission tomography of prostate-specific membrane antigen-positive lesions, including selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan prostate-specific membrane antigen-directed therapy is indicated. Locametz is the first radioactive diagnostic agent approved for patient selection in the use of a radioligand therapeutic agent.

Patients with previously treated metastatic castration-resistant prostate cancer should be selected for treatment with Pluvicto using Locametz or another approved prostate-specific membrane antigen-11 imaging agent based on prostate-specific membrane antigen expression in tumors. Prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer was defined as having at least one tumor lesion with gallium Ga 68 gozetotide uptake greater than normal liver. Patients were excluded from enrollment if any lesions exceeding certain size criteria in the short axis had uptake less than or equal to uptake in normal liver.

Efficacy was evaluated in VISION, a randomized 2:1, multicenter, open-label trial that evaluated Pluvicto plus best standard of care or best standard of care alone in men with progressive, prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. All patients received a gonadotropin releasing hormone analog or had prior bilateral orchiectomy. Patients were required to have received at least one androgen receptor pathway inhibitor, and 1 or 2 prior taxane-based chemotherapy regimens.

The trial demonstrated a statistically significant improvement in the primary endpoints of overall survival and radiographic progression-free survival. Hazard ratio for overall survival was 0.62 for the comparison of Pluvicto plus best standard of care versus best standard of care. Median overall survival was 15.3 months in the Pluvicto plus best standard of care arm and 11.3 months in the best standard of care arm, respectively. Interpretation of the magnitude of the radiographic progression-free survival effect was limited due to a high degree of censoring from early drop out in the control arm.

The most common adverse reactions reported in more than 20% of patients receiving Pluvicto were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline in more than 30% of patients receiving Pluvicto were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. Treatment with Pluvicto may result in risk from radiation exposure, myelosuppression, and renal toxicity. The safety follow-up duration in VISION was not sufficient to capture late radiation-associated toxicities.

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 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.

                                                                                  Content current as of:
      04/22/2022Resources 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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