A New Drug Approval- Erleada ™ (apalutamide) For Non-Metastatic Castration-Resistant Prostate Cancer

Yesterday, the FDA approved a new advanced hormone therapy drug (a next-generation androgen receptor inhibitor) for the treatment of men with non-metastatic castration-resistant prostate cancer (NM-CRPC). This drug with the trade name Erleada (aka apalutamide), is the first drug approved in this disease space. 

  • ERLEADA™ is the first FDA-approved therapy to treat men with non-metastatic castration-resistant prostate cancer (however, the existence of local lymph nodes does not exclude a man from qualifying for this drug).
  • Approval is based on Phase 3 SPARTAN clinical trial data which showed ERLEADA™ decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years 
  • The major efficacy outcome was supported by statistically significant improvements for secondary endpoints, including time to metastasis, progression-free survival, and time to symptomatic progression

Erleada which is manufactured by the Janssen Pharmaceutical Companies of Johnson & Johnson, was approved based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in men with NM-CRPC.

“The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “We are excited about what this approval means for patients living with prostate cancer, and that physicians now have an important and much-needed treatment option that has been shown to delay the progression of castration-resistant prostate cancer.

“The SPARTAN trial results demonstrated impressive clinical benefits in patients with non-metastatic castration-resistant prostate cancer,” said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School, and co-principal investigator of the SPARTAN study. “As an oncologist and clinical investigator, I know how devastating it can be for patients and their families to hear that the cancer has spread. With this approval, doctors now have the chance to offer hope for delaying metastases in patients with castration-resistant prostate cancer.”

Like all other drugs, there are side effects for men taking Erleada.  Warnings and Precautions include seizure, falls and fractures.4 In the SPARTAN trial, the most common adverse reactions (≥10%) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral edema.


About this Disease Space - Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (NM-CRPC) refers to a disease state when the cancer no longer responds to medical or surgical treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan or CT scan.[5] Features include lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL  Ninety percent of men with CRPC will eventually develop bone metastases, which can lead to pain, fractures, and spinal cord compression. The relative 5-year survival rate for men with distant stage prostate cancer is 30 percent.  It is critical to delay the onset of metastasis in patients with NM-CRPC.

·       Information is taken from a press release from Janssen Pharmaceutical Companies of Johnson & Johnson

Joel T. Nowak, MA, MSW wrote this Post.  Joel is the CEO/Executive Director of Cancer ABCs.  He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.