ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the availability of an additional tablet strength of ERLEADA® (apalutamide) in the United States. The introduction of the 240mg tablet provides the first-and-only option for a once-daily, single-tablet Androgen Receptor Inhibitor (ARI) approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
With two strengths available, healthcare professionals will have the flexibility to prescribe the approved 240mg once-daily dose of ERLEADA®in either one 240mg tablet or four 60mg tablets. The single-tablet option may be preferable for patients in need of reducing their total number of daily pills.
ERLEADA®remains the only ARI with labeling to include approved alternate methods of administration for patients who have difficulty swallowing tablets whole. The 60mg tablets continue to have an approved option for dispersing with applesauce, while the 240mg tablet is approved for dispersing in orange juice, water or applesauce. The 240mg tablet may also be administered through a feeding tube.
“Each person and their cancer are unique and, as such, there is no one-size-fits-all approach to treatment,” said Luca Dezzani, M.D., Vice President, Medical Affairs, Solid Tumor, Janssen Scientific Affairs, LLC. “The availability of 240mg and 60mg strength options of ERLEADA®demonstrates Janssen’s commitment to prostate cancer patients and provides prescribers flexibility in dosing and methods of administration to fit each patient’s unique needs.”
Both tablet strengths are available via prescription through existing specialty pharmacy networks.
ERLEADA® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). ERLEADA® received U.S. Food and Administration (FDA) approval for nmCRPC in February 2018, and received U.S. FDA approval for mCSPC in September 2019.To date, more than 100,000 patients worldwide have been treated with ERLEADA®.