Bayer is about 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 asserting {that a} Part III trial with the remedy met its major endpoint.
The corporate didn’t disclose detailed trial information, solely stating that the mixture of Nubeqa and androgen deprivation remedy (ADT) demonstrated “a statistically vital and clinically significant enhance”, in comparison with the placebo and ADT mixture, within the radiological progression-free survival (rPFS), the research’s major endpoint. Bayer plans to share the detailed outcomes from the trial at an upcoming scientific convention.
Nubeqa has been authorised 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 further chemotherapy. To that finish, Bayer plans to submit the Part III ARANOTE trial information for regulatory approval.
“Following potential regulatory approval, physicians will be capable of tailor Nubeqa therapy 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 trying ahead to future outcomes of our medical growth program investigating the compound throughout a number of prostate most cancers phases and indications.”
Nubeqa is an androgen receptor inhibitor (ARi), which was first authorised 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.
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Bayer can also be evaluating the Nubeqa and ADT mixture in non-metastatic HSPC sufferers within the Part 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 Part III DASL-HiCaP research (NCT04136353).
