The U.S. FDA Approved Johnson & Johnson AKEEGA™ for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

Johnson & Johnson’s Janssen Pharmaceutical AKEEGA

Johnson & Johnson (JNJ) owned Janssen Pharmaceutical announced that the U.S. FDA has approved AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC), which no longer responds to androgen deprivation therapy and has spread to other parts of the body as detected by an FDA-approved test. The most common metastasis occurs in the bones, followed by the lungs and liver. Prostate cancer is the second most common cancer in men worldwide, behind lung cancer. Each year, more than one million patients are diagnosed with prostate cancer worldwide.  Patients with mCRPC and HRR gene alterations, of which BRCA mutations are the most common, to have aggressive disease, poor outcomes and a shorter survival time.

The most common prostate metastatic sites are the bones, followed by the lungs and the liver. Prostate cancer is the second most common cancer in men behind lung cancer. More than one million patients around the world are diagnosed with prostate cancer each year. Patients with mCRPC and HRR gene alterations, of which BRCA mutations are the most common, are more likely to have aggressive disease, poor outcomes and a shorter survival time. 

From the Experts

Kim Chi, M.D., Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Phase 3 MAGNITUDE study of AKEEGA said, “As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have BRCA mutation, We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”

Prostate cancer is common in the U.S., with around 288,300 new cases and nearly 35,000 deaths expected in 2023. Around 10 to 15 percent of patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) have BRCA gene alterations. Patients with BRCA-positive mCRPC are more likely to have aggressive disease and may experience poor outcomes and a shorter survival time.

Shelby Moneer, MS, CHES, Vice President of Patient Programs and Education, ZERO Prostate Cancer said, “The approval of AKEEGA brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease. All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes. This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes.”

The FDA approval is based on positive results from Phase 3 MAGNITUDE study.

A statistically significant 47 percent risk reduction was observed for radiographic progression-free survival (rPFS)In BRCA-positive patients treated with the combination AKEEGA™ plus prednisone,

At the IA2, with median follow-up at 24.8 months in the BRCA-positive subgroup, radiographic progression-free survival by central review demonstrated a consistent trend favoring AKEEGA™ plus prednisone, with a median rPFS of 19.5 months compared with 10.9 months for placebo and AAP (HR, 0.55 [95 percent confidence interval (CI), 0.39-0.78]).

The observed safety profile of the combination of AKEEGA™ plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy

Adverse Effects

Of the patients in the MAGNITUDE study with a BRCA gene alteration, 41% who received AKEEGA™ experienced a serious adverse event.  The most common AEs occurring in 20 percent or more of patients who received AKEEGA™ plus prednisone versus patients who received placebo and AAP were musculoskeletal pain (44 percent vs. 42 percent, respectively), fatigue (43 percent vs. 30 percent), constipation (34 percent vs. 20 percent), hypertension (33 percent vs. 27 percent) and nausea (33 percent vs. 21 percent).

Permanent discontinuation of any component of AKEEGA™ due to an adverse reaction occurred in 15 percent of patients.

Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC said, “Janssen’s legacy of advancing the science of prostate cancer contributed to the evolution of transformational treatment approaches for more than a decade  This milestone, which marks the approval of Janssen’s third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC.”


AKEEGA™ is the first-and-only orally administered, once daily dual action tablet (DAT) of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, an androgen biosynthesis inhibitor. The novel DAT combination therapy targets two oncogenic drivers in patients with mCRPC and HRR gene alterations. AKEEGA™ is indicated with prednisone for the treatment of adults with mCRPC and BRCA-positive mutations. The recommended starting dose is 200 mg niraparib/1,000 mg abiraterone acetate (two tablets). The 100 mg niraparib/1,000 mg abiraterone acetate dose option (two tablets) is available for dose reduction.

In April 2016, Janssen Biotech, Inc. entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GlaxoSmithKline [GSK] in 2019) for exclusive rights to niraparib in prostate cancer.

MAGNITUDE (NCT03748641) is a Phase 3, randomized, double-blind, placebo-controlled, multi-center clinical study evaluating the safety and efficacy of the combination of AKEEGA™ plus prednisone for patients with mCRPC, with or without certain HRR gene alterations, and who have not received prior therapy for mCRPC except for up to four months of AAP.

The study included patients with (HRR biomarker [BM] positive; ATM, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, PALB2) and without specified gene alterations (HRR BM negative), who were randomized 1:1 to receive niraparib 200 mg once daily plus AAP or placebo plus AAP. 

A total of 423 patients with HRR gene alterations were enrolled, 225 (53.2 percent) of whom had BRCA mutations The primary endpoint of the MAGNITUDE trial was rPFS assessed by blinded independent central review. Secondary endpoints included TCC, TSP and OS. Analysis of the group of patients with BRCA alterations was alpha controlled for rPFS and prespecified for other endpoints.

Access to AKEEGA™ (niraparib and abiraterone acetate)

Once a patient and their doctor have decided that AKEEGA™ is right for the patient, Janssen can help find the resources patients may need to get started and stay on therapy. Janssen offers support navigating the payer processes to assist patients in gaining access to AKEEGA™. Janssen can provide information on insurance coverage and potential out-of-pocket costs and identify options that may help make AKEEGA™ more affordable.

If patients have commercial or private health insurance and need help paying for AKEEGA™, the Janssen CarePath Savings Program may be able to help.

To learn more about access and affordability support visit or call 1-877-CarePath (1-877-227-3728).

Janssen offer personalized support for patients that provides one-on-one guidance, information, and educational resources, which includes helping them explore cost support options.

Patients can get connected to dedicated support from our Care Navigators by calling Janssen Compass® directly at 844-628-1234 or by visiting and requesting an introductory call. Janssen Compass® is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient’s understanding of their therapy and is not intended to provide medical advice, replace a treatment plan from the patient’s doctor or nurse, provide case management services, or serve as a reason to prescribe a Janssen medication.

Read the Important Safety Information about AKEEGA™ and  the precautions at the company’s website

Prohost Observations

The United States FDA approval of Johnson & Johnson’s AKEEGA™ for BRCA-Positive Metastatic Castration-Resistant Prostate Cancer is extremely important and needed. AKEEGA can save the lives of the patients who have lost all kind of hope for survival. The AKEEGA™ plus prednisone trial results demonstrated a significantly improved radiographic progression-free survival compared to abiraterone acetate plus prednisone (AAP) in patients with BRCA-positive mCRPC.

Following AKEEGA’s FDA approval, the oncologists will now require ordering  the FDA approved test  to use the product.  Now all the patients who are diagnosed with prostate cancer should better take the FDA approved test that can diagnose BRCA-Positive Metastatic Castration-Resistant Prostate Cancer. The patients must  better do the test  even before the cancer starts to resist the drugs  and procedures treatments,. With the test results in doctors’ hands, they will know how to treat their patients prostate cancers early. 

This approval is definitely good news.  

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