Bayer's blockbuster hopeful Nubeqa debuts in later-stage prostate cancer in UK under early access program

Thanks to a new early access deal and the intercontinental oncology effort Project Orbis, England will be the first European country where patients with later-stage prostate cancer can get their hands on Bayer’s Nubeqa.

Monday, Bayer said the U.K. is rolling out Nubeqa in tandem with androgen deprivation therapy (ADT) and the chemotherapy docetaxel “immediately,” following a speedy approval in metastatic hormone-sensitive prostate cancer (mHSPC) from the Medicines and Healthcare Products Regulatory Agency.

The accelerated approval comes under the regulatory program called Project Orbis, an international team-up between drug regulators in countries like the U.K., the U.S. and Australia. It's designed to hasten the approval process for promising cancer meds, NHS England explains.

In the U.K., Nubeqa, also known as darolutamide, first won a license to treat non-metastatic castration-resistant disease in 2020. Stateside, the drug is already approved to treat both mHSPC and non-metastatic castration-resistant prostate cancer.

With a U.K. approval in hand, Bayer has locked in a deal with the NHS—which was the first healthcare system in Europe to fast-track the medicine—enabling doctors to arrange early access to Nubeqa for eligible patients in England while local cost watchdog NICE completes its assessment of the drug.

The British signoff leveraged data from the late-stage ARASENS trial. The study of 1,305 patients showed Nubeqa combined with ADT and docetaxel helped patients slash the risk of death by 32.5% versus ADT and chemotherapy alone. Alongside that statistically significant result, Bayer’s Nubeqa trial also looked at secondary endpoints time to pain progression and time to first symptomatic skeletal event.

Nubeqa’s safety was generally on par with the control arm, “despite longer treatment exposure for those treated with darolutamide,” Bayer explain in a release, referring to Nubeqa by its generic name.

Nubeqa—which Bayer developed together with Finnish pharmaceutical outfit Orion Corporation—has enjoyed a strong 2022, recently nearly doubling sales to 127 million euros in the year’s third quarter. Shortly after that revenue win, Nubeqa nabbed another win on its path to blockbuster territory.

In early August, the FDA’s Real-Time Oncology Review Pilot blessed the drug with its U.S. mHSPC green light, clearing the way for Nubeqa in later-stage disease.

By widening the reach of the blockbuster-to-be in prostate cancer, Bayer has said Nubeqa could eventually clinch peak sales between 1 billion euros ($1.1 billion) and 3 billion euros ($3.4 billion).