FDA Approved Bayer’s Nubeqa for Metastatic Castration-Sensitive Prostate Cancer

The FDA has recently approved Bayer’s oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), a serious form of prostate cancer.

The approval is based on results from the phase 3 ARANOTE trial, which showed Nubeqa, when combined with androgen deprivation therapy (ADT), reduced the risk of radiographic progression or death by 46% compared to ADT with placebo.

Prostate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of cancer death among men worldwide.

According to the drug’s website, men taking Nubeqa typically pay an average of $454 per month with Medicare coverage—though most pay under $50—while those with commercial insurance pay an average of $210 per month, with eligible patients potentially paying as little as $0 through the NUBEQA $0 Co-Pay Program.

The drug’s cost is a critical factor for patients and healthcare providers, as prostate cancer therapies often involve long-term treatment, according to Bayer.

Nubeqa is now FDA-approved for both non-metastatic castration-resistant prostate cancer (nmCRPC) and mCSPC, including use with or without the chemotherapy drug docetaxel.

The drug works by inhibiting the androgen receptor, which plays a central role in the growth of prostate cancer cells.

Unlike some other androgen receptor (AR) inhibitors, Nubeqa has a certain chemical structure that may lead to fewer side effects and drug interactions, offering a potentially more ideal option for patients who need a well-tolerated, long-term treatment.

Prostate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of cancer death among men worldwide.

In 2020, there were an estimated 1.4 million new prostate cancer cases and nearly 375,000 deaths globally.

In the U.S. alone, almost 300,000 men were diagnosed with the disease.

About 10% of patients are diagnosed with mCSPC from the start, which means their cancer has already spread beyond the prostate and is still sensitive to hormone therapy.

The drugs approval for this disease was based on the phase 3 trial which enrolled 669 patients, who were randomized in a 2:1 ratio to receive either 600 mg of Nubeqa twice daily with ADT or a placebo with ADT.

The primary endpoint was radiographic progression-free survival (rPFS), a measure of time until cancer growth was seen on scans or the patient died.

The trial found consistent benefits across patient subgroups.

For example, men with high-volume disease had a 40% reduction in risk of progression or death, while those with low-volume disease saw a 70% reduction.

The safety profile of the drug remained consistent in the trial.

Serious adverse events occurred in 24% of patients in both the Nubeqa and placebo groups, and treatment discontinuation due to side effects was lower in the Nubeqa group (6%) than in the placebo group (9%).

Christine Roth, executive vice president of global product strategy and commercialization at Bayer, called the approval “an important milestone” that “underscores our commitment to delivering meaningful outcomes for patients and their families.”

Prostate cancer treatment has changed rapidly over the past decade, according to Bayer.

At diagnosis, most patients have localized cancer that can be treated with surgery or radiation.

However, once the disease spreads or relapses, systemic therapy—starting with ADT—is crucial.

mCSPC patients are typically treated with hormone therapy alone or in combination with AR inhibitors or chemotherapy.

While effective initially, most patients eventually progress to castration-resistant prostate cancer, which has poorer outcomes.

With its FDA approval for mCSPC, the drug offers a new, evidence-supported option to potentially delay that progression and improve quality of life for men facing this aggressive form of prostate cancer.