Bayer is ready to pursue a label growth for Nubeqa (darolutamide) in a definite subgroup of prostate most cancers sufferers—these with metastatic hormone-sensitive prostate most cancers (mHSPC)—after saying {that a} Section III trial with the remedy met its major endpoint.
The corporate didn’t disclose detailed trial knowledge, solely stating that the mixture of Nubeqa and androgen deprivation remedy (ADT) demonstrated “a statistically important and clinically significant improve”, in comparison with the placebo and ADT mixture, within the radiological progression-free survival (rPFS), the examine’s major endpoint. Bayer plans to share the detailed outcomes from the trial at an upcoming scientific convention.
Nubeqa has been permitted by the US Meals and Drug Administration (FDA) to deal with sufferers with mHSPC, however solely together with docetaxel chemotherapy. The corporate now plans to hunt approval for the drug’s use mHSPC indication sans extra chemotherapy. To that finish, Bayer plans to submit the Section III ARANOTE trial knowledge for regulatory approval.
“Following potential regulatory approval, physicians will be capable of tailor Nubeqa remedy plans with or with out docetaxel based mostly on particular person affected person’s wants,” mentioned Christian Rommel, head of analysis and growth at Bayer’s prescribed drugs division.
“[These] outcomes construct on the established efficacy and tolerability profile of NUBEQA. We’re wanting ahead to future outcomes of our scientific growth program investigating the compound throughout a number of prostate most cancers levels and indications.”
Nubeqa is an androgen receptor inhibitor (ARi), which was first permitted by the US FDA to deal with metastatic castration-resistant prostate most cancers (mCRPC). The remedy generated €869m ($949m) in gross sales final 12 months, as per Bayer’s financials. Nubeqa gross sales are anticipated to extend to over $3.6bn in 2029, as per GlobalData evaluation, as the corporate seeks to broaden its use in a number of subgroups of prostate most cancers sufferers.
Entry probably the most complete Firm Profiles
available on the market, powered by GlobalData. Save hours of analysis. Achieve aggressive edge.
Firm Profile – free
pattern
Your obtain e mail will arrive shortly
We’re assured in regards to the
distinctive
high quality of our Firm Profiles. Nevertheless, we would like you to take advantage of
helpful
choice for what you are promoting, so we provide a free pattern you could obtain by
submitting the beneath type
By GlobalData
GlobalData is the guardian firm of Pharmaceutical Expertise.
Bayer can also be evaluating the Nubeqa and ADT mixture in non-metastatic HSPC sufferers within the Section III ARASTEP trial (NCT05794906). The Australian and New Zealand Urogenital and Prostate Most cancers Trials Group (ANZUP) is evaluating Nubeqa as an adjunct remedy for localised prostate most cancers with a really excessive danger of recurrence in a Section III DASL-HiCaP examine (NCT04136353).
