Life’s been tough for Johnson & Johnson’s prostate cancer med Erleada as it battles archrival Xtandi from Pfizer and Astellas. Lagging behind its competitor in the nonmetastatic form of the disease, Erleada can take solace in having a new indication to work with.
The FDA on Tuesday approved Erleada as an add-on to androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer—which covers around 40,000 new patients in the U.S. each year, J&J said in a release.
Erleada’s green light follows the FDA’s real-time review of the drug’s phase 3 Titan trial data, which showed Erleada plus ADT cut the risk of death over placebo plus ADT by 33%. After nearly two years, 84% of patients on Erleada-ADT were still alive, compared with 78% of the placebo-ADT group.
In January, J&J halted the Titan trial early based on those findings. At the time, an independent data monitoring committee recommended placebo-plus-ADT patients switch over into the Erleada arm.
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A new indication for Erleada will help the drug steel itself for battle with Xtandi, which has the sales lead and is looking for new indications of its own.
In late August, the FDA granted Xtandi a priority review to treat metastatic, hormone-sensitive prostate cancer, which could open the drug up to 38,000 new patients each year. In a phase 3 trial, dubbed Arches, a combo of Xtandi and ADT reduced the risk of cancer worsening or death by 61% versus ADT alone. In a second investigator-sponsored study called Enzamet, Xtandi pared down the risk of death by 33% compared with other non-steroidal androgen-fighting drugs.
With an FDA decision for Xtandi expected in early 2020, Erleada will also be tasked with taking on a new competitor in the field after Bayer and Orion’s Nubeqa received an FDA nod of its own in prostate cancer in July.
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Nubeqa, despite lagging significantly behind its earlier-launching rivals, will likely lean on strong safety data in non-metastatic castration-resistant prostate cancer (nmCRPC), an indication that both Xtandi and Erleada boast, Bernstein analyst Wimal Kapadia wrote to clients in February.
In Nubeqa’s phase 3 Aramis trial, the drug plus ADT exhibited a median metastasis-free survival of 40.4 months, versus 18.4 months for placebo plus ADT. Despite the limitations in comparing clinical trials face-to-face, Erleada posted a median MFS of 40.4 months versus 16.2 months for placebo, and Xtandi hit 36.6 months versus placebo’s 14.7 months.
All those drugs will be competing for sales in a market Xtandi has so far dominated since its launch in nmCRPC in July of last year. In the second quarter, Pfizer posted $201 million in U.S. sales of the med—an 18% jump from the same period in the previous year.
