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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RELEVANCE
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
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 (abiraterone and ), while the other half received abiraterone without niraparib. All participants received prednisone.
- After two years, compared to people with a BRCA1 or BRCA2 mutation who had a plus prednisone, people with a BRCA1 or BRCA2 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 (niraparib plus abiraterone acetate) combines the PARP inhibitor niraparib () and abiraterone acetate (Zytiga) into one pill. Like other PARP inhibitors, Akeega can be particularly effective against cancers with mutations in BRCA1 and BRCA2.
The most common side effects in either the Akeega group or abiraterone 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 placebo group. Lower back pain was more common in the placebo group compared to the Akeega group.
Expert Guidelines
The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with metastatic prostate cancer.
- Testing for MSI-H/dMMR may help identify patients who would benefit from immunotherapy.
- 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 tumor mutational burden (TMB-H) may benefit from immunotherapy.
Updated: 03/01/2023
Expert Guidelines
The National Comprehensive Cancer Network guidelines recommend genetic counseling and testing for the following people with prostate cancer who have:
- a tumor test result that suggests an inherited mutation
- for example, a tumor with a BRCA1, BRCA2 or mutation may indicate an inherited mutation in one of those genes
- a blood relative who tested positive for an inherited mutation in a gene linked to prostate cancer
- metastatic prostate cancer diagnosed at any age
- prostate cancer that has spread to the
- localized prostate cancer (hasn’t spread beyond the prostate) that is considered very high-risk or high-risk
- intermediate-risk prostate 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
- metastatic, regional, very-high-risk, or high-risk prostate cancer at any age
- one or more close relatives with prostate 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, prostate 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
The following organizations offer peer support services for people with or at high risk for prostate cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Prostate Cancer is a nonprofit organization that provides information and support resources for men with prostate cancer.
Updated: 03/08/2023