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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancerResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Lynparza (olaparib), with abiraterone and prednisone, for BRCA-mutated metastatic castration-resistant prostate cancer
  
  	
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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 May 31, 2023, the FDA approved olaparib (brand name Lynparza) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

Efficacy was evaluated in the PROpel trial that enrolled 796 patients with metastatic castration-resistant prostate cancer. Patients were randomized 1:1 to receive either olaparib with abiraterone or placebo with abiraterone and also received prednisone or prednisolone. Patients were required to have a prior orchiectomy and, if not performed, received gonadotropin-releasing hormone analogs. Patients with prior systemic therapy for metastatic castration-resistant prostate cancer were excluded; however, prior docetaxel for metastatic hormone-sensitive prostate cancer was allowed. Randomization was stratified by site of metastases and prior docetaxel.

The major efficacy outcome measure was investigator-assessed radiological progression-free survival per RECIST version 1.1 for soft tissue and Prostate Cancer Working Group criteria for bone lesions. Overall survival was an additional endpoint.

A statistically significant improvement in radiological progression-free survival for olaparib with abiraterone compared to placebo with abiraterone in the intent-to-treat population was observed. An exploratory subgroup analysis in the 85 patients with BRCA-mutated demonstrated a median radiological progression-free survival that was not reached in the olaparib with abiraterone arm compared to 8 months for those receiving placebo with abiraterone. The overall survival hazard ratio in these patients was 0.30. In the 711 patients without BRCA-mutated, the radiological progression-free survival hazard ratio was 0.77 and the overall survival hazard ratio was 0.92, suggesting that the improvement in radiological progression-free survival observed in the intent-to-treat population was primarily attributable to patients with BRCA-mutated.

The most common adverse reactions occurring in more than 10% in patients receiving olaparib plus abiraterone were anemia, fatigue, nausea, diarrhea, decreased appetite, lymphopenia, dizziness, and abdominal pain. Seventy-two patients required at least one blood transfusion and 46 required multiple transfusions.

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

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:
      07/13/2023Resources 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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