J&J’s apalutamide scores snap FDA approval in castration-resistant prostate cancer subgroup

pharmafile | February 15, 2018 | News story | Sales and Marketing Cancer, Erleada, FDA, J&J, JJ, Johsnon & Johnson, apalutamide, pharma, prostate cancer 

Johnson & Johnson has announced that its androgen receptor inhibitor apalutamide, now branded as Erleada, has received approval from the FDA for the treatment of non-metastatic castration-resistant prostate cancer that continues to grow despite the administration of hormone therapy, just a week after it made public strong new data in the same indication.

The decision was made on the back of this data which demonstrated that Erleada reduced the risk of distant metastasis or death by 72%, in addition to increasing median metastasis-free survival by more than two years in the study’s 1,207 participants.  

The decision was also the first of its kind, as Richard Pazdur, Director of the FDA’s Oncology Center of Excellence and acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, noted: “This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumours did not spread to other parts of the body or that death occurred after starting treatment. In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.”

Research from the National Institutes of Health indicates that prostate cancer is the second most common form of cancer in the US, while 161,360 men were diagnosed with the disease throughout 2017; 26,730 were expected to die as a result that same year. Between 10% and 20% of all prostate cancer cases are castration-resistant.

“As the impact of prostate cancer continues to grow, we are reminded every day of the critical need for therapeutic options that offer patients with prostate cancer more time with their loved ones,” remarked Dr Mark Scholz, Executive Director of the Prostate Cancer Research Institute. “Today’s approval is significant, as it means that patients with non-metastatic castration-resistant prostate cancer now have a treatment option that offers renewed hope.”

Matt Fellows

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