J&J eyes prostate cancer boost as FDA accepts Erleada for real-time review

Johnson & Johnson has fallen behind the Pfizer-Astellas team with Erleada in the drug’s first approved indication. But now it looks poised to bring in another.

The FDA accepted the New Jersey drugmaker’s application to expand Erleada’s reach to patients with metastatic, castration-sensitive prostate cancer, it said this week. And the agency will examine the filing under its Real-Time Oncology Review program, an efficiency measure meant to allow it to start leafing through data before a drugmaker formally submits a complete application.

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The news follows J&J’s January announcement that investigators had halted a phase 3 study of Erleada, combined with androgen deprivation therapy (ADT), after the regimen showed it could significantly stave off disease progression and lengthen lives. At the time, an independent data monitoring committee recommended placebo-plus-ADT patients switch over into the Erleada arm.

If the company can bag an OK, it’ll help J&J boost sales as Zytiga, Erleada’s predecessor, faces generic competition. And it’ll back up Erleada’s current indication in nonmetastatic castration-resistant prostate cancer (CRPC).

According to J&J’s archrival, the Pfizer-Astellas duo—makers of Xtandi—Erleada could use some help in that department. Xtandi currently holds “more than double” Erleada’s share in nonmetastatic CRPC, Pfizer biopharma President Angela Hwang told investors on Pfizer’s first-quarter conference call, despite Erleada’s head start in the market.

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But Pfizer and Astellas aren’t just sitting around waiting for Erleada to catch fire. Last summer, they accelerated the timelines for two Xtandi trials, including one dubbed Arches testing Xtandi-plus-ADT versus ADT alone in metastatic hormone-sensitive patients.