Update: News from the FDA: Updates on metastatic prostate cancer treatment

RELEVANCE

Most relevant for: People with metastatic prostate cancer.

It may also be relevant for:

• people with castration-resistant prostate cancer
• people with castration-sensitive prostate cancer
• people with metastatic or advanced cancer
• people with prostate cancer

Relevance: High

Research Timeline: Post Approval

More rating details

What is this update about?

The FDA approved two new drugs, Akeega and Nubeqa, to treat metastatic, castration-sensitive prostate cancer. This type of prostate cancer has spread beyond the prostate but still responds to hormone-lowering treatment (also called androgen deprivation therapy or ADT). Description of Akeega is provided below and of Nubeqa is in the next section.

Akeega

Akeega is a drug treatment that combines two drugs: Zejula (niraparib) and Zytiga (abiraterone). Zejula is a type of targeted therapy known as a PARP inhibitor. Zytiga (also available in generic form under several brand names) can slow prostate tumor growth by blocking specific hormones in the body.

Akeega was originally approved in 2023 to treat metastatic castration-resistant prostate cancer (mCRPC) in people with a tumor mutation in BRCA1 or BRCA2. Akeega is now approved to treat metastatic castration-sensitive prostate cancer (mCSPC) in people who have a BRCA2 tumor mutation. (An FDA-approved test can be used to check tumors for BRCA2 mutations.) As a part of treatment, Akeega is taken together with prednisone, a type of steroid.

Why is this update important?

The expanded approval of Akeega adds a treatment option for people who have metastatic castration-sensitive prostate cancer with a BRCA2 mutation.

FDA approval was based on results from the AMPLITUDE trial. Study participants who received Akeega had a longer time before their cancers grew, based on imaging tests (radiographic progression-free survival), compared to those who received a placebo. Both groups also received prednisone and a drug to lower testosterone levels. Researchers continue to collect overall survival data, and while early trends are encouraging, a clear survival benefit has not yet been confirmed.

Potential side effects include:

• Fewer red and white blood cells
• Decreased potassium levels, which can affect nerves, muscles and heart rhythm
• Fluid retention
• Heart or blood cardiovascular problems
• Liver problems
• Decreased levels of hormones made by the adrenal glands
• Low blood sugar
• Increased risk of bone fractures

Rare but serious side effects have been reported, including certain blood or bone marrow disorders. Very rare cases of reversible brain swelling were seen in clinical trials. Your care team will monitor closely for these effects

What does this mean for me?

If you are diagnosed with metastatic castration-sensitive prostate cancer (mCSPC), your doctor can order a test to see if Akeega may be an option for your treatment. For some, Akeega can extend the time before mCSPC grows. If you are treated with Akeega, consider discussing the impact of the potential side effects, approaches to reduce or manage those side effects and quality of life with your medical provider.

Reference

FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. U.S. Food and Drug Administration. Published December 12, 2025. Accessed January 15, 2026.

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 2/13/26

The FDA recently approved Nubeqa (darolutamide) for men with metastatic castration-sensitive prostate cancer (mCSPC). Nubeqa is a type of hormone therapy known as an androgen receptor inhibitor. Nubeqa was originally approved to treat non-metastatic castration-resistant prostate cancer. Previously, in the mCSPC setting, Nubeqa was only approved when used with chemotherapy (docetaxel). Men may now take Nubeqa with standard hormone treatment without chemotherapy.

Why is this update important?

This approval provides an additional treatment option for men who don’t require or cannot tolerate chemotherapy. Nubeqa can help slow the growth and spread of prostate cancer, extending the time it remains under control. Having more time before the cancer worsens can help men stay active, maintain their quality of life and plan for future treatment options.

The study that led to the approval:
The Nubeqa approval was based on the ARANOTE study, which included 669 men with mCSPC. All study participants received hormone therapy (ADT).

• Group 1: Received Nubeqa + hormone therapy
   
• Group 2: Received placebo (no active drug) + hormone therapy

What the study found:

• Men who took Nubeqa went much longer before imaging scans showed signs of the cancer worsening.
• At the time of this study, the cancer had not yet progressed in many men taking Nubeqa, while those on placebo saw their cancer worsen in about 25 months.
• At the time of the study, overall survival (living longer) was not significantly different between the two groups, but results showed a clear delay in disease progression in those who took Nubeqa.

Common side effects:

Side effects were generally similar to those already found with Nubeqa, and most men tolerated it well. Possible side effects and risks include:

• Heart-related problems (such as reduced blood flow to the heart)
• Seizures (rare)
• Risks to an unborn baby if taken during pregnancy (precautions are needed for partners who may become pregnant)
• Nubeqa, like other hormone-based treatments, can affect fertility, which may be temporary or permanent

What does this mean for me?

If you have metastatic castration-sensitive prostate cancer (mCSPC), this new FDA approval means you may now have the option of treatment with Nubeqa without chemotherapy.

Nubeqa combined with hormone therapy can help slow the growth and spread of your cancer, potentially keeping it under control for longer. This delay in disease progression may allow you to stay active, maintain your quality of life and plan for future treatments.

References

FDA approves darolutamide for metastatic castration-sensitive prostate cancer. U.S. Food and Drug Administration. June 3, 2025.

Saad F, Vjaters E, Shore ND, et al. Efficacy and safety of darolutamide plus androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. Journal of Clinical Oncology. 2024;42(36):4271–4281.

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.

Share your thoughts on this XRAY review by taking our brief survey.  

posted 2/13/26

What is this update about?

Pluvicto is a drug that targets prostate cancer cells with a biomarker called PSMA (prostate-specific membrane antigen) and delivers radiation directly to these cells.  It is used to treat metastatic castration-resistant prostate cancer (mCRPC).

Pluvicto was originally approved in 2022 for patients who previously received anti-androgen drugs and chemotherapy. In March 2025, the FDA expanded the use of Pluvicto to include patients who have been treated with androgen receptor pathway inhibitors before chemotherapy, allowing earlier access to this targeted radiation therapy.

Why is this update important?

It provides a new treatment option for men with PSMA-positive mCRPC earlier in their treatment journey. Pluvicto delivers radiation directly to the cancer cells, helping to kill or damage cancer cells while helping limit exposure to healthy tissues compared with traditional chemotherapy

Common side effects:

Patients may experience side effects, most of which are manageable and may include:

• Fatigue
• Nausea
• Dry mouth
• Low blood counts (such as anemia, low white cells or low platelets)
• Kidney or liver function changes (monitored by your doctor)

What does this mean for me?

If you have mCRPC, your doctor can order a PSMA PET scan to decide if Pluvicto may be an option for you. If your prostate cancer expresses PSMA, Pluvicto may provide a targeted treatment option earlier in your therapy journey, potentially delaying chemotherapy.

Reference

FDA expands Pluvicto's prostate cancer indication. U.S. Food and Drug Administration. Published March 28, 2025. Accessed September 9, 2025.

FDA expands Pluvicto indication for earlier use in patients with prostate cancer. Healio. Published March 28, 2025. Accessed September 9, 2025.  

Pluvicto (lutetium Lu-177 vipivotide tetraxetan) [prescribing information]. U.S. Food and Drug Administration. Published 2025. Accessed September 9, 2025.  

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.

Share your thoughts on this XRAY review by taking our brief survey.  

posted 2/13/26