A First For Prostate Cancer: Janssen's Erleada Approved For Non-Metastatic Patients
J&J subsidiary Janssen's Erleada (apalutamide) is the first therapy approved for non-metastatic castration-resistant prostate cancer (nmCRPC). The US FDA decision came about two months early, but the drug – priced at $10,920 per month, or $131,040 annually – may soon face competition.
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Erleada was approved for treatment of metastatic castration-sensitive prostate cancer (mCSPC), strengthening its position versus generic Zytiga and Pfizer/Astellas's Xtandi.
Johnson & Johnson has solid growth drivers in pharmaceuticals, but still faces an overhang related to talc controversy; Bristol's call will be dominated by the just-announced Celgene acquisition; and AbbVie will face questions about its cancer plans after expensive failure with Rova-T.
Protocol changes for the Phase III ARCHES and EMBARK trials will deliver results in hormone-sensitive prostate cancer a year and a half earlier than expected. Xtandi may then gain a valuable new indication sooner than anticipated, but generics for competitor Zytiga could launch before then.