Darolutamide (ODM-201) in the treatment of nmCRPC

Earlier this year we had reported on the initial presentation of data demonstrating the efficacy and safety of darolutamide (formerly known as ODM-201), a third “super-antiandrogen” — similar to enzalutamide (Xtandi) and apalutamide (Erleada), in the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC).

For those who are interested, the full report on the results of the ARAMIS trial has now been published in the New England Journal of Medicine. Unfortunately, however, only the abstract of the paper by Fizazi et al. is available on line. The information provided in this abstract confirms the information presented by Dr. Fizazi at the Genitourinary Cancers meeting in February this year.

We are still expecting to see darolutamide gain FDA approval, here in the US, some time in the next 6 months or so. Approval of this drug by other regulatory agencies around the world can also reasonably be expected in a timely fashion.

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