Bayer has blockbuster hopes for prostate cancer med Nubeqa, and a new endorsement from the U.K.’s National Institute for Health and Care Excellence (NICE) provides another milestone toward that goal.
After an approval last November to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), Bayer inked a deal with officials in England to make the drug available to certain patients under an early access program.
Now, thanks to NICE's endorsement in combination with androgen deprivation therapy and the chemotherapy docetaxel, the drug will be available to more patients in England and Wales, Bayer said in a release. Already, a "few hundred" patients with mHSPC have received the drug, according to Bayer.
The drug scored its mHSPC approval in England last November thanks to late-stage data showing that the combination cut the risk of death by 32.5% compared with placebo.
Previously, the drug had carried a NICE endorsement to treat patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease.
Nubeqa is a key growth driver for Bayer. Last year, the company tripled its peak sales projection for the drug to more than 3 billion euros. The company wants to make the drug a "foundational" therapy "across the entire spectrum of prostate cancer,” Bayer's former head of oncology, Robert LaCaze, said in an interview with Fierce Pharma at the time.
While Nubeqa still has a ways to go toward that goal, the drug is quickly becoming a growth star for Bayer. During this year’s first quarter, the med reached sales of 178 million euros ($194 million), a 134% increase from last year’s first quarter.
In the U.S., Nubeqa scored an expanded FDA approval in mHSPC last August after its original 2019 approval in non-metastatic castration-resistant prostate cancer.
Meanwhile, AstraZeneca’s growth driver Forxiga also scored a new NICE nod recently. Specifically, the agency endorsed the drug to treat symptomatic chronic heart failure with preserved or mild reduced ejection fraction.
The drug, which is also approved to treat chronic kidney disease and Type 2 diabetes, is now the first NICE-recommended treatment for this specific type of heart failure.
In the U.S., AstraZeneca markets the drug as Farxiga.
AZ's Farxiga brought in $1.29 billion worldwide during this year’s first quarter, a 30% increase from the same period last year.

Reference: https://www.fiercepharma.com/pharma/bayers-blockbuster-hopeful-nubeqa-astrazenecas-farxiga-pick-nods-englands-nice