29May

Bayer Healthcare and Orion's Nubeqa (darolutamide) in Non-metastatic castration-resistant prostate cancer (nmCRPC)

bayer healthcare and orion's nubeqa

ASCO 2020 Virtual is happening from May 29 to May 31, and it is exciting to watch major Oncology Pharmaceutical companies and their key presentations.

Bayer Healthcare and Orion Corporation both the companies are worth mentioning here, as they are presenting key posters and studies on nmCRPC.

Nubeqa (darolutamide) History:

In June 2014, Orion and Bayer entered a global agreement for the development and commercialization of the compound ODM-201 which is also known as darolutamide, an investigational novel oral androgen receptor inhibitor. Under the terms of the agreement, Bayer AG paid USD 68 Million upfront for Orion Corporation's prostate cancer candidate ODM-201.

Nubeqa (darolutamide) Facts:

Nubeqa is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS).

In the year 2019, Nubeqa (darolutamide) was granted fast track designation by the US FDA for the men with nmCRPC cancer.

As per Delveinsight analysis, Nubeqa has blockbuster potential and is expected to generate a noteworthy revenue of more than USD 1 billion in its peak year after the successful launch in the market. 

Nubeqa (darolutamide) Approval History:

In July 2019, the US Food and Drug Administration (FDA) approved darolutamide, for non-metastatic castration-resistant prostate cancer.

In March 2020, the European Commission has granted marketing authorization in the European Union (EU) for Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).

In January 2020, the Japanese Ministry of Health, Labor, and Welfare (MHLW) granted marketing authorization to Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC).

Key abstracts/Posters:

#Abstract 5514:

Overall survival (OS) results of phase III ARAMIS study of darolutamide (DARO) added to androgen deprivation therapy (ADT) for non-metastatic castration-resistant prostate cancer (nmCRPC)

Significance: Darolutamide safety and tolerability for men affected with nmCRPC.  

#Abstract5561:

Safety outcomes of darolutamide versus apalutamide and enzalutamide in non-metastatic castration-resistant prostate cancer (nmCRPC): Matching-adjusted indirect comparisons

Significance: Darolutamide safety and tolerability for men affected with nmCRPC.  

#Abstract TPS5587:

DaroACT: Darolutamide and enzalutamide effects on physical and neurocognitive function and daily activity in patients with castration-resistant prostate cancer (CRPC)

Significance: Progress of the trial and other trial-related details. 

#Abstract TPS5593:

DAROL: DARolutamide ObservationaL study patients in nonmetastatic castration-resistant prostate cancer (nmCRPC) patients

Significance: Progress of the trial and other trial-related details.