Just under a year since J&J won approval from the FDA to start marketing Erleada (apalutamide) for non-metastatic prostate cancer, the pharma giant has now nailed down the late-stage data it needs to prove that it works in metastatic patients as well.
The pharma giant said Wednesday morning that the monitoring committee on the TITAN study called it, flagging the study for its success on both the co-primaries: radiographic progression-free survival as well as overall survival. The actual data will be posted later this year with as much fanfare as the company will be able to muster.
The drug is a mainstay for J&J’s cancer drug portfolio, a blockbuster successor to the best-selling therapy Zytiga as generic competition looms for that franchise. Zytiga and Pfizer’s Xtandi have been duking it out for the prostate cancer market with their androgen receptor inhibition approach to castration-resistant cases.
J&J recruited more than 1,050 patients with metastatic cases who were randomized to receive either Erleada plus androgen deprivation therapy, or placebo plus ADT. They were treated “until disease progression or the occurrence of unacceptable treatment related toxicity, or end of treatment.” Patients in the control arm can now cross over to J&J’s combo.
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