Pfizer’s Xtandi approvable in nmCRPC followed by Bayer/Orion’s darolutamide; Xtandi, J&J’s Erleada’s familiarity casts uptake challenge for darolutamide, experts say

18 May 2018

Pfizer’s (NYSE:PFE) Xtandi (enzalutamide) is likely to receive an expanded label approval in nonmetastatic castration-resistant prostate cancer (nmCRPC) due to strong Phase III data and its well-understood MOA, experts said. Phase III metastatic-free survival (MFS) success was similar to Johnson & Johnson’s (NYSE:JNJ) already approved Erleada (apalutamide), prompting confidence for Pfizer’s nonsteroidal antiandrogen (NSAA) to enter the market for first-line competition, they noted.

While Bayer (ETR:BAYN) and Orion’s (HEL:ORNBV) darolutamide could achieve similar Phase III efficacy and approval outcomes, its late market entry spells a market share struggle, experts said. This is despite Bayer/Orion’s claims of lower blood brain barrier (BBB) penetration, which analysts say could give it a superior safety profile. Some interviewed noted that darolutamide’s preclinical signs of affinity for mutated androgen receptors (ARs) could help differentiate it, though more work needs to be done to ascertain that potential.

Analysts note there is sufficient space for healthy sales growth among the competing products due to the significant unmet need in nmCRPC. Erleada was approved in February, with expected nmCRPC sales of USD 1.23bn in 2022, while Xtandi’s PDUFA is expected in July and has projected sales of USD 1.4bn for nmCRPC. Analysts believe Erleada’s first-approved status provides Johnson & Johnson (J&J) a modest advantage, despite a lack of efficacy differentiation between Erleada’s and Xtandi’s pivotal trials.

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