Look out, Pfizer. With new approval, Bayer's Nubeqa is set to challenge Xtandi's prostate cancer crown

After a strong sales showing last week, Bayer’s ascendant oncology star Nubeqa has put on an encore performance, this time wooing regulators to win its second U.S. nod.

The FDA has blessed Nubeqa with an approval to treat adults with metastatic hormone-sensitive prostate cancer (mHSPC). The green light clears the way for Nubeqa in later-stage disease, as well as non-metastatic castration-resistant prostate cancer (nmCRPC)—the indication where the med bagged its original approval back in 2019.

Friday’s green light, approved under the FDA’s Real-Time Oncology Review (RTOR) pilot, covers a triple combination of Nubeqa with the chemotherapy docetaxel, plus androgen deprivation therapy (ADT).

In a release, Bayer pointed out that Nubeqa is the only androgen receptor inhibitor (ARi) cleared in combination with docetaxel for mHSPC.

By widening the reach of the blockbuster-to-be in prostate cancer, Bayer figures Nubeqa could eventually clinch peak sales between 1 billion euros ($1.1 billion) and 3 billion euros ($3.4 billion). Bayer upped that forecast from previous guidance based on positive results from the phase 3 Arasens trial, which showed Nubeqa plus standard-care chemotherapy docetaxel and ADT slashed the risk of death in mHSPC patients by 32.5%.

Nubeqa also fared well on safety, with similar incidences of side effects in both the study drug and control arms that ranged from rash and loss of appetite to hemorrhage and hypertension. Serious side effects cropped up in 45% of patients on the Nubeqa-chemo combo, versus 42% of patients on chemotherapy alone. Fatal side effects occurred in 4% of patients in both Arasens’ study drug and control cohorts.

“The expansion of Nubeqa’s indication to reach a broader population in the U.S. reaffirms Bayer’s commitment to provide proven and tolerable treatment options to eligible patients across different stages of prostate cancer,” Christine Roth, member of the executive committee of Bayer’s pharmaceutical division and head of oncology, said in a statement.

Apart from hitting its overall survival endpoint in Arasens, meanwhile, Nubeqa charted a “statistically significant delay in time to pain progression,” Bayer noted.

The label expansion portends a showdown between Nubeqa and Pfizer and Astellas’ Xtandi, which was originally approved in mCRPC in 2012. Xtandi snagged its non-metastatic nod in 2018. That drug pulled down sales of $4.2 billion in 2021.

Nubeqa will also be jockeying for space alongside Johnson & Johnson’s Erleada, greenlit in 2018, which brought home revenues of $1.3 billion last year.

Prostate cancer is the second-leading cancer-related cause of death among men in the U.S., Bayer points out. Up to one-third of patients eventually develop metastatic disease. What’s more, rates of mHSPC have spiked 72% in the U.S. over the past decade, Bayer adds. Roughly one-third of patients who are diagnosed with mHSPC survive for five years or more, with most eventually progressing to castration-resistant prostate cancer.

It's been a good few months for Nubeqa, which doubled sales during 2022’s second quarter to 105 million euros ($106.7 million), Bayer reported last week. Still, the med has a long way to go before it breaks the blockbuster barrier. Friday’s green light may put it one step closer.

Editor’s note: This story was updated to correct the timing of Xtandi’s non-metastatic castration-resistant prostate cancer approval.