PCRI’s Executive Director, Mark Scholz, MD, announces that Erleada (apalutamide) has been FDA-approved for use in a new group of prostate cancer patients. Up until now, Erleada was only FDA-approved for the treatment of castrate-resistant prostate cancer (that is, prostate cancer that is resistant to Lupron or another first-generation hormone treatment) but now, Erleada has been approved for concurrent use with Lupron (or a Lupron type drug) in men with metastatic castrate-sensitive disease.
0:12 Erleada is a second-generation hormonal treatment that is effective at treating advanced prostate cancer. Up until now, it has only been used to treat prostate cancer that was resistant to first-generation treatments (Casodex, Lupron, etc.) known as "castrate-resistant prostate cancer."
0:27 A large 1000-person prospective trial was conducted to test Erleada's effectiveness when added to Lupron in men with metastatic castrate-sensitive prostate cancer. Researchers found improved survival and better outcomes in men when Erleada was added to Lupron. Hence, the FDA approved Erleada for the treatment of this stage of prostate cancer.
0:45 Men with metastatic castrate-sensitive prostate cancer are usually in a situation in which, for whatever reason, their PSAs were not being monitored and it rose to a very high level without treatment. Historically, they would be treated with Lupron alone, Lupron plus chemotherapy (e.g. Taxotere), or Lupron plus Zytiga (another second-generation hormonal agent).
1:39 Erleada is typically well-tolerated. Some men experience a rash, but in most cases, there are no additional side effects than when Lupron is taken alone.
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