U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Eli Lilly has in the past few months unveiled two back-to-back trial flops for Verzenio in prostate cancer. Now, we know exactly how one sputtered.
Lilly’s growth drivers, Verzenio and Jardiance, suffer setbacks
AKEEGA™ (niraparib and abiraterone acetate) Now Available from Onco360
LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone Approved in Japan for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On August 11, 2023, the Food and Drug Administration approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
Mylan`s Abiraterone Acetate Receives Approval in Europe
MISSISSAUGA, ON, July 13, 2023 /CNW/ - Health Canada has granted a Notice of Compliance with Conditions (NOC/c) for Lynparza® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before Lynparza treatment is initiated.1
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca and Merck & Co., Inc’s, known as MSD outside the US and Canada, LYNPARZA® (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.