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news.Bayer has secured approval from the US Food and Drug Administration (FDA) for its Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
Image: Nubeqa (darolutamide) tablets. Photo: courtesy of PRNewsfoto/Bayer.
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The approval was based on data from the phase III ARAMIS trial, which assessed Nubeqa plus androgen deprivation therapy (ADT).
According to the company, the trial showed a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) with a median of 40.4 months against 18.4 months for placebo plus ADT.
Bayer, along with Finnish pharmaceutical firm Orion, has developed Nubeqa, an androgen receptor inhibitor (ARi).
The drug features a specific chemical structure, which competitively inhibits androgen binding and AR-mediated transcription.
ARAMIS is a randomised, double-blind, placebo-controlled and multi-centre phase III study designed to assess the safety and efficacy of oral Nubeqa in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy.
The company has randomised 1,509 patients in a 2:1 ratio in the study to secure 600mg of Nubeqa orally twice daily or placebo plus ADT. The MFS is the primary efficacy endpoint of the trial.
Nubeqa also secured approval to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is also being assessed in the ongoing phase III study in metastatic hormone-sensitive prostate cancer (ARASENS).
The company has also submitted applications for approval of Nubeqa in the European Union (EU) and Japan, as well as other health authorities.
Bayer oncology strategic business unit head Robert LaCaze said: “With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC.
“Bayer is proud to take this latest step forward in the nmCRPC treatment landscape. Nubeqa is the newest addition to our prostate cancer portfolio and reflects Bayer’s commitment to finding treatments for men at different stages along the prostate cancer continuum.”
In March this year, Bayer entered into a $775m settlement agreement with Janssen Pharmaceuticals to resolve litigation related with blood thinner medication Xarelto.
Xarelto is a prescription medicine used to decrease the risk of stroke and blood clots in patients with atrial fibrillation, which is not caused by a heart valve problem.
