MedOncMD

To provide the information your oncologist is not telling you or doesn't have the time to!

  • Home
  • Blog
    • The essentials
    • Art of Oncology
    • Prevention and Healthy Lifestyle
    • Research Advances
    • Navigation Corner
    • Video Library
  • Meet and Greet
    • About Dr Thomas
    • About Dr Landau
  • Ask MedOncMD?
  • 🧠 How I Create My Blog Posts

Unlocking Hope: FDA Greenlights Enzalutamide for Non-Metastatic Prostate Cancer with Biochemical Recurrence

by MedOncMD on December 14, 2023

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.

At MedOncMD, a diverse array of valuable information is at your disposal, covering various aspects of cancer care, raising awareness, strategies for prevention, sustaining a healthy lifestyle, and staying updated with the latest research developments. Join our Cancer Support and awareness group!


About the author

Dr. Daniel Landau, a distinguished board-certified hematologist/oncologist, has built a commendable career spanning two eminent institutions: the Orlando Health Cancer Institute and the Medical University of South Carolina

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.

Recent Posts

  • Why I Occasionally Attend Pharmaceutical Speaker Dinners — And What I Take From Them
  • President Biden’s Metastatic Prostate Cancer Diagnosis: A Look Through the Oncologist’s Lens
  • From Fatal to Beatable: How Science Turned the Tide on a Deadly Leukemia
  • Belated but Unbroken: An Oncologist’s Mother’s Day Reflection
  • When Cancer Moves Fast: Understanding Visceral Crisis and Urgent Oncologic Decisions

Categories

  • Art of Oncology (81)
  • Current News (13)
  • Immunotherapy News (9)
  • Navigation Corner (6)
  • Prevention and Healthy Lifestyle (18)
  • Research Advances (108)
    • Clinical Trials (43)
    • Immunotherapy (29)
    • New Treatments and Therapies (42)
  • The essentials (41)
    • Radiology (4)
  • Travel Health (1)
  • Uncategorized (10)
  • Varied Cancer Perspectives (116)
    • Biliary tract cancer (3)
    • Bladder Cancer (3)
    • Breast Cancer (10)
    • Cervical Cancer (2)
    • CNS Cancers (1)
    • Colorectal cancer (13)
    • Esophageal Cancer (2)
    • Gastric cancer (6)
    • Hepatic Tumors (1)
    • Leiomyosarcoma (2)
    • Leukemia (3)
    • Lung Cancer (10)
    • Lymphoma (3)
    • Melanoma (28)
    • Multiple Myeloma (3)
    • Neuroendocrine cancer (2)
    • Ovarian Cancer (3)
    • Pancreatic Cancer (5)
    • Prostate Cancer (5)
    • Sarcoma (2)
    • Sickle Cell Disease (4)
    • Skin Cancer (7)
    • Thyroid cancer (1)
    • Urothelial Cancer (1)
  • Video (2)
  • Weekly Newsletter (6)

Get in touch!

  • Facebook
  • Instagram
  • TikTok
  • LinkedIn


Meet the authors

Dr. Sajeve Thomas
Dr Daniel Landau


Subscribe


  • Home
  • Blog
    • The essentials
    • Art of Oncology
    • Prevention and Healthy Lifestyle
    • Research Advances
    • Navigation Corner
    • Video Library
  • Meet and Greet
    • About Dr Thomas
    • About Dr Landau
  • Ask MedOncMD?
  • 🧠 How I Create My Blog Posts
© 2025 MedOncMD. Minimal Theme by SPYR
✕
  • Home
  • Blog
    • The essentials
    • Art of Oncology
    • Prevention and Healthy Lifestyle
    • Research Advances
    • Navigation Corner
    • Video Library
  • Meet and Greet
    • About Dr Thomas
    • About Dr Landau
  • Ask MedOncMD?
  • 🧠 How I Create My Blog Posts