FDA speeds Bayer's J&J-Pfizer showdown with darolutamide 'priority'

Johnson & Johnson and the Pfizer-Astellas team have grown accustomed to a two-horse race in prostate cancer. But it may not be long before a third joins them.

The FDA bestowed its priority review tag on Bayer and Orion’s darolutamide, a candidate up for approval in non-metastatic, castration-resistant prostate cancer (CRPC). The move ensures a speedy trip down the regulatory pathway for the prospect, which also bears the agency’s fast-track designation.

For darolutamide’s potential rivals, that means less time to grab market share before new competition hits the scene—and competition that may have a best-in-class safety profile, no less.

At least, that’s the word from Bernstein analyst Wimal Kapadia, who wrote to clients in February that darolutamide’s "very clean safety profile" looks "superior to competitors’." Considering the side effects that can come along with J&J's new Erleada and Pfizer and Astellas' Xtandi—"falls/fractures, hypertension, rash, fatigue and CNS adverse events"—it’s difficult "to argue against the superior safety on this data," Kapadia noted.

For now, though, it’s Xtandi that’s dominating the non-metastatic CRPC field with a slice of the pie that’s "more than double" Erleada’s, Pfizer biopharma president Angela Hwang said earlier this week on the drug giant’s first-quarter conference call. Pfizer’s lead comes despite Erleada’s head start; it nabbed its FDA go-ahead in the indication last February, five months before Xtandi got the green light.

Bayer, though, is hoping darolutamide can make a dent in that market—and provide some backup for the rest of its oncology portfolio. Key cancer drugs Stivarga and Xofigo have struggled in recent quarters, though both bounced back in the first quarter to top analyst expectations.

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