In a groundbreaking move, the Food and Drug Administration (FDA) has granted approval for enzalutamide (Xtandi, Astellas Pharma US, Inc.) to address non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence. This significant development brings renewed hope for patients at high risk for metastasis.
The Road to Approval: EMBARK Trial Insights
In the EMBARK clinical trial (NCT02319837), involving 1068 patients with nmCSPC and high-risk biochemical recurrence, enzalutamide showcased its potential. Patients, who had undergone definitive therapy such as radical prostatectomy or radiotherapy, were enrolled in a randomized 1:1:1 trial. The trial assessed the efficacy of enzalutamide in combination with leuprolide, enzalutamide monotherapy, and a placebo with leuprolide.
Key Findings: Metastasis-Free Survival (MFS) Takes Center Stage
The primary measure of success was metastasis-free survival (MFS), evaluated through blinded independent central review. Enzalutamide, either as a monotherapy or in combination with leuprolide, demonstrated a statistically significant improvement in MFS compared to the placebo with leuprolide. The hazard ratios and p-values underscore the efficacy of enzalutamide in delaying disease progression.
Adverse Reactions: Understanding and Managing
Patients undergoing enzalutamide treatment, either with leuprolide or as a monotherapy, experienced common adverse reactions such as hot flushes, musculoskeletal pain, fatigue, and hemorrhage. Understanding these side effects is crucial for patients, their families, and healthcare providers to ensure a balanced approach to treatment.
Navigating Treatment: Dosage and Administration Insights
For those embarking on enzalutamide treatment, the recommended dose is 160 mg administered orally once daily, with or without food. The flexibility of administration and the option to suspend treatment based on PSA levels offer personalized care to patients.
Global Collaboration: Project Orbis Spearheads Progress
This FDA approval falls under Project Orbis, an initiative promoting international collaboration in the simultaneous submission and review of oncology drugs. The FDA collaborated with Health Canada and Switzerland’s Swissmedic, emphasizing the global effort to advance cancer care.
Efficiency and Timeliness: Real-Time Oncology Review (RTOR) and Ahead-of-Schedule Approval
The review process utilized the Real-Time Oncology Review (RTOR) pilot program, streamlining data submission. Remarkably, the FDA approved the application five weeks ahead of the goal date, showcasing the commitment to expediting access to promising treatments.
A Beacon of Hope in Cancer Care
As we embrace this milestone, the FDA’s approval of enzalutamide opens new doors for patients, families, and healthcare providers grappling with non-metastatic castration-sensitive prostate cancer. This comprehensive guide aims to empower, educate, and inspire as we navigate this transformative journey together.
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About the author
Dr. Daniel Landau is a distinguished board-certified hematologist/oncologist renowned for his exceptional contributions in the field. With an illustrious career spanning across esteemed institutions like the Orlando Health Cancer Institute and the Medical University of South Carolina, Dr. Landau’s expertise shines in both genitourinary oncology and hematology.