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Update: New drug combination approved for treatment of BRCA-mutated metastatic prostate cancer


The FDA approved Akeega (niraparib and abiraterone) plus prednisone for the treatment of BRCA-mutated, metastatic castration-resistant prostate cancer (mCRPC). Akeega can be used as an early or later treatment. (Posted 11/9/23)

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New drug combination approved for treatment of BRCA-mutated metastatic prostate cancer
Glossary on


Most relevant for: People with metastatic castration resistant prostate cancer with a mutation in BRCA1 or BRCA2.
It may also be relevant for:

  • people with castration-resistant prostate cancer
  • people with a family history of cancer
  • people with a genetic mutation linked to cancer risk
  • people with metastatic or advanced cancer

Relevance: Medium-High

Research Timeline: Post Approval

Relevance Rating Details

What is this update about?

The has approved Akeega in combination with prednisone as a treatment for castration-resistant cancer (mCRPC) for people with or mutation. Akeega combines acetate and the niraparib into a single tablet.  

This approval is based on the results of a large clinical trial called MAGNITUDE. Participants were divided into two groups. Half of them received Akeega ( and ), while the other half received without . All participants received prednisone.

  • After two years, compared to people with a or mutation who had a plus prednisone, people with a or mutation who had Akeega plus prednisone:
    • reduced their risk of cancer progressing or death by 45%. 
    • went longer without needing chemotherapy.
    • went longer without symptoms of cancer progression (such as the need for bone surgery).
    • had improved patient-reported outcomes, including a 30% delay in time-to-pain progression and a 33% delay in time-to-pain interval that interfered with daily activities.

About Akeega

Akeega ( plus acetate) combines the niraparib () and acetate (Zytiga) into one pill. Like other PARP inhibitors, Akeega can be particularly effective against cancers with mutations in and .

The most common side effects in either the Akeega group or group were:

  • Anemia (low red blood cell counts)
  • High blood pressure (hypertension)
  • Constipation
  • Lower back pain

Anemia, high blood pressure and constipation were more common in the Akeega group compared to the group. Lower back pain was more common in the group compared to the Akeega group.

What does this mean for me?

Genetic testing and tumor testing for people with mCRPC

  • Experts recommend genetic testing for an linked to cancer for everyone diagnosed with mCRPC. Results from this test may affect your treatment options.
  • Experts also recommend tumor testing for people with mCRPC to see whether they would benefit from treatment with a . If you have not had tumor testing or you are unsure if you have had it, ask your doctor about ordering additional tests.
  • If genetic testing or tumor testing shows that you have a mutation in or , you may benefit from treatment with Akeega.
  • If genetic testing or tumor testing shows that you have a mutation in another gene, you may benefit from a or another type of .

You can find more information on and for mCRPC here.


approves and acetate plus prednisone for BRCA-mutated castration-resistant cancer. news release. August 11, 2023.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 11/9/23

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • What is my cancer?
  • Is my cancer castration-resistant?
  • What options do I have for treating my cancer?
  • Should I have tumor testing or genetic testing?
  • What side effects may occur with my cancer treatment?

Open clinical trials
Open clinical trials

The following studies are looking at PARP inhibitors and similar agents for treating people with advanced  cancer.  

Other clinical trials for people with  cancer can be found here.

Updated: 11/09/2023

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with prostate cancer.

  • Testing for MSI-H/dMMR may help identify patients who would benefit from .  
  • Testing for tumor mutations in HRR genes may help identify patients who would benefit from PARP inhibitors.
  • Consider testing for a marker known as (TMB). People with a high (TMB-H) may benefit from

Updated: 03/01/2023

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network guidelines recommend genetic counseling and testing for the following people with  cancer who have:

  • a tumor test result that suggests an inherited mutation
    • for example, a tumor with a  or  mutation may indicate an in one of those genes 
  • a blood relative who tested positive for an  in a gene linked to  cancer
  •   cancer diagnosed at any age
  • cancer that has spread to the
  • localized cancer (hasn’t spread beyond the ) that is considered very high-risk or high-risk
  • intermediate-risk cancer with intraductal or cribriform features listed on the
  • a diagnosis of male breast cancer
  • Eastern European (Ashkenazi) Jewish ancestry
  • one or more relatives with:
    • breast, colorectal or endometrial cancer diagnosed at age 50 or younger
    • male breast cancer, triple negative breast cancer, ovarian cancer or pancreatic cancer at any age
    • , regional, very-high-risk, or high-risk cancer at any age
  • one or more close relatives with cancer diagnosed at age 60 or younger
  • three or more relatives on the same side of the family with biliary tract, breast, colorectal, endometrial, glioblastoma, or other cancers

Speak with a genetic counselor if you have questions about whether you meet guidelines for genetic testing. 

Updated: 02/01/2024

Peer Support
Peer Support

The following organizations offer peer support services for people with or at high risk for cancer:

Updated: 03/08/2023

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