The FDA has awarded a priority review status to Bayer’s darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
The move comes just two months after Bayer, and darolutamide-partner Orion, revealed positive late-stage data for the non-steroidal androgen receptor inhibitor.
Known as ARAMIS, the phase 3 programme evaluated the safety and efficacy of darolutamide in patients with nmCRPC who are currently being treated with androgen deprivation therapy (ADT) and are at high risk of their cancer metastasising.
The drug reduced the risk of this happening, along with risk of death, by 59%, achieving a median metastasis free survival of 40.4 months, versus 18.4 months in the placebo arm. There was also an increase in overall survival of 29% versus placebo.
Once approved, the drug will go up against Johnson & Johnson’s Zytiga (with the first generics now reaching the market), its follow-up Erleada, and Pfizer/Astellas’ Xtandi.
Darolutamide won’t have an easy time competing in against these products, however, as its efficacy profile is very similar to that of Erleada and Xtandi.
The hope for Bayer’s drug is that has the potential for lower toxicity, as the molecule doesn’t cross the blood-brain barrier, which could result in less CNS toxicity and fewer drug-drug interactions.
Current androgen antagonists are associated with a range of side effects including fractures, falls, seizures, and weight loss, but in ARAMIS darolutamide seemed to exhibit placebo-like tolerability, with only fatigue occurring significantly more often than control. Bayer reckons that tolerability is critical in non-metastatic CRPC because patients may be on therapy for years,
The big question is whether that will be enough to differentiate the drug from its rivals, particularly as Zytiga generics have reached the US market.
For these reasons, analysts at Evaluate Pharma predict darolutamide’s market penetration will be somewhat limited, reaching a respectable but unexceptional level of $819m in 2024.
“Darolutamide is highly effective in the patient population with non-metastatic castration-resistant prostate cancer, and it has few adverse effects with a profile that parallels that of placebo. We are looking forward to taking the next steps in bringing darolutamide to men with nmCRPC and their treating physicians,” concludes Christer Nordstedt, senior vice president, Research and Development, Orion Corporation.