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Update: New first-line treatment option for metastatic prostate cancer

The FDA has approved Talzenna (talazoparib) with Xtandi (enzalutamide) as first-line treatments for some patients with metastatic castration-resistant prostate cancer. (Posted 10/2/23)

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RELEVANCE

Most relevant for: People with metastatic castration resistant prostate cancer who have an inherited or tumor mutation in certain genes..

It may also be relevant for:

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

Relevance: Medium-High

Research Timeline: Post Approval

More rating details

What is this update about?

The (Food and Drug Administration) approved together with Xtandi as a treatment for people with castration-resistant cancer (mCRPC). This approval is for people who have an or tumor mutation in the following genes: , , , ATR, CDK12, , FANCA, MLH1*, MRE11A, , or . is given with Xtandi, which is already used to treat prostate cancer.

*Although mutations are included in the approval, works differently to repair damage than the other listed genes.

Why is this update important?

prostate cancer can be hard to treat, but effective first treatments may help people live longer and healthier lives. This approval offers a new first treatment for some mCRPC.

About these treatments

Xtandi is standard hormone therapy used to treat mCRPC. It works by blocking testosterone.

is a type of known as a . Several different PARP inhibitors are used to treat mCRPC. In addition to being used for cancer,  PARP inhibitors also treat certain breast, ovarian and pancreatic cancers.

The research behind the approval

This approval is based on the results of a clinical trial called TALAPRO-2. Half of the participants in the trial took Xtandi with . The other half took Xtandi and a sugar pill (). Neither the participants nor the doctors knew who took and who took the . and Xtandi improved outcomes for all people with mCRPCs. However, people whose tumors had mutations in certain genes responded especially well to this drug combination.

People who took went longer without their cancer growing or spreading than participants who received the . Early results suggest that people with a mutations may respond especially well to . The drug greatly reduced the risk of cancer spreading in people with a mutation compared to people without a gene mutation.

Side effects

The most common side effects of were low red blood cells and fatigue. Participants in the trial also experienced other side effects, including lower appetite, dizziness, nausea, fractures and changes to taste. Low mineral (sodium, calcium, magnesium and potassium) levels were also common.

Among people taking , about 2 in 5 needed at least one blood transfusion, and 1 in 5 needed multiple transfusions. Two people on the trial developed leukemia.

What does this mean for me?

Experts recommend that everyone with mCRPC have genetic testing for an linked to cancer. Results from this test may affect your treatment options and may also help your relatives learn about their risk for cancer and take steps to prevent cancer. If you have mCRPC and have not had genetic testing, ask your doctor for a referral for genetic counseling and testing.

Experts also recommend that people with mCRPC have tumor testing to see if they would benefit from treatment with a . If you have not had tumor testing or you are unsure if your tumor tissue has been tested, ask your doctor about ordering additional tests. If genetic or tumor testing shows that you have a mutation in , , , ATR, CDK12, , FANCA, , MRE11A, , or , you may benefit from treatment with . If you have a mutation in a different gene, you may still benefit from a or another type of .  

If you have not had surgery to remove both testicles ( orchiectomy) you may need to take a drug which blocks testosterone production.

Reference

approves with for HRR gene-mutated castration-resistant cancer. news release. June 20, 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 10/2/23

Questions To Ask Your Doctor

  • Should I have genetic testing for a mutation in genes linked to cancer? 
  • Should I have tumor testing?
  • Is or another an option for me?
  • Will my health insurance pay for ?

Open Clinical Trials

The following treatment studies are enrolling people with advanced  cancer: 

The following studies are enrolling people with advanced , including cancer: 

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

 

 

Updated: 10/03/2025

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

Related Resources

The following resources focus on  cancer. 

Updated: 01/30/2025

Expert Guidelines

The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment or eligibility for clinical trials for people with prostate cancer. The recommendation highlights the following considerations:

  • Biomarkers may change when cancer grows or worsens. A repeat biopsy and tumor testing may be needed when cancer progresses. 
  • Tumor testing may find inherited mutations. People with a tumor mutation that may be inherited are recommended to have genetic counseling with a genetics expert followed by genetic testing.

The NCCN recommends the following tests:

  • Testing for MSI-H/dMMR to identify patients who would benefit from .  
  • Testing for tumor mutations in to identify patients who would benefit from PARP inhibitors.
  • Testing for (TMB) to identify patients with a high (TMB-H) who may benefit from . 
  • Additional testing as required for clinical trial eligibility.

Updated: 09/29/2025

Article Rating Details

Study Rating Details

Relevance: Medium-High

  • Talzenna plus Xtandi can now be used as a first-line treatment for people with mCRPC who have an inherited or tumor mutation in some DNA repair genes.
  • This approval is not for people with other types of prostate cancer or who do not have an inherited or tumor mutation in an HRR gene.

Research Timeline:  Post-approval