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CME/CE

FDA Approvals: Radium-223 for Advanced Prostate Cancer

  • Authors: News Author: Zosia Chustecka
    CME Author: Laurie Barclay, MD
  • CME/CE Released: 7/3/2013
  • THIS ACTIVITY HAS EXPIRED FOR CREDIT
  • Valid for credit through: 7/3/2014, 11:59 PM EST
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Target Audience and Goal Statement

This article is intended for primary care clinicians, oncologists, urologists, and other specialists who care for patients with prostate cancer.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe a new FDA approval of a radiopharmaceutical agent for use in the treatment of prostate cancer.
  2. Describe the efficacy of radium-223 dichloride, based on data from the pivotal phase 3 ALSYMPCA trial.
  3. Describe the safety of radium-223 dichloride, based on data from the pivotal phase 3 ALSYMPCA trial.


Disclosures

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Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Zosia Chustecka

    Zosia Chustecka is the News Editor for Medscape Oncology. A pharmacology graduate based in London, UK, she has edited and written extensively for publications aimed at clinician audiences. Winner of a 2011 Award for Excellence in Urology Health Reporting for an article on prostate cancer, her work also has been recognized by the British Medical Journalists Association, and recently she was awarded a Harvard University Fellowship on Cancer Genetics (May 2011) as well as a US National Press Foundation Cancer Issues Fellowship (October 2010). She can be reached at [email protected].

    Disclosures

    Disclosure: Zosia Chustecka has disclosed no relevant financial relationships.

Editor(s)

  • Laurie E. Scudder, DNP, NP

    Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

    Disclosures

    Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

CME Author(s)

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Joi Tisdale

    CME Program Manager, Medscape, LLC

    Disclosures

    Disclosure: Joi Tisdale has disclosed no relevant financial relationships.


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CME/CE

FDA Approvals: Radium-223 for Advanced Prostate Cancer

Authors: News Author: Zosia Chustecka CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME/CE Released: 7/3/2013

Valid for credit through: 7/3/2014, 11:59 PM EST

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Clinical Context

Radium-223 dichloride is a novel radiopharmaceutical agent that binds to minerals in the bone. By delivering radiation directly to bone tumors, this agent limits damage to surrounding normal tissues. When osteoblasts take up radium-223, it emits alpha radiation, causing double-strand DNA breaks that kill prostate cancer cells at sites of increased bone turnover.

Most patients with advanced prostate cancer (approximately 90%) develop bone metastases, and many of these do not have detectable metastases to other organ systems. Because radium-223 dichloride specifically targets bone metastases, it could be of potential therapeutic benefit in many different cancers that have spread to the bone, regardless of the primary tumor.

Study Synopsis and Perspective

A novel radiopharmaceutical agent has been approved by the US Food and Drug Administration (FDA) for use in the treatment of prostate cancer.

The product, radium-223 dichloride (formerly known as Alpharadin), will be marketed as Xofigo for use in men with symptomatic metastatic castration-resistant prostate cancer that has spread to the bone but not to other organs. It is intended for men whose cancer has spread after medical or surgical therapy to lower testosterone levels, according to the FDA.

The FDA reviewed the product under its priority program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists or offer significant improvement over products on the market. It was approved more than 3 months ahead of schedule.

Radium-223 dichloride "binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research.

The product, administered once a month by intravenous injection, contains the isotope radium-223, which is taken up by osteoblasts and then emits alpha radiation. This causes double-strand DNA breaks that are lethal to the prostate cancer cell at the site of increased bone turnover induced by the cancer.

Radium-223 dichloride has minimal myelosuppression, is well tolerated, and is associated with an overall survival benefit.1

  1. Parker C, Nilsson S, Heinrich D, et al. Updated analysis of the phase III, double-blind, randomized, multinational study of radium-223 chloride in castration-resistant prostate cancer (CRPC) patients with bone metastases (ALSYMPCA). Program and abstracts of the American Society of Clinical Oncology Annual Meeting and Exposition; June 1-5, 2012; Chicago, Illinois. Abstract LBA4512.

The survival data come from the pivotal phase 3 ALSYMPCA trial, which involved 809 prostate cancer patients who were resistant to hormone treatment and had developed 2 or more bone metastases. All of the participants received standard treatment, but the men who also received radium-223 chloride lived significantly longer. An interim analysis revealed a median overall survival of 14.0 months, compared with 11.2 months (hazard ratio, 0.695; P = .00185), and the trial was stopped because of benefit.

An exploratory updated analysis confirmed the product's ability to extend overall survival, according to the FDA.

The most common adverse effects of radium-233 dichloride seen during clinical trials were nausea; diarrhea; vomiting; and swelling of the leg, ankle, or foot.

Radium-223 dichloride is highly targeted for bone metastases, so it is possible that it could be used in many different cancers that have spread to the bone, regardless of primary site, said lead investigator Chris Parker, MD, consultant clinical oncologist at the Royal Marsden Hospital in London, United Kingdom. Prostate cancer patients were studied in the first instance because this cancer has a high tendency to metastasize to the bone, Dr. Parker explained. About 90% of patients with advanced prostate cancer will develop bone metastases and, in many cases, there will not be any detectable metastases elsewhere in the body, he said.

More information on the FDA approval of radium-223 is available on the FDA Web site.

Clinical Implications

  • The FDA has approved radium-223 dichloride, a new radiopharmaceutical agent, for use in men with symptomatic castration-resistant prostate cancer that has metastasized to the bone but not to other organs. It was approved more than 3 months ahead of schedule under the FDA priority program. Administration is once monthly by intravenous injection.
  • Data from the pivotal phase 3 ALSYMPCA trial suggest an impressive, statistically significant overall survival benefit for radium-223 dichloride. Median overall survival duration with standard treatment and radium-223 dichloride was 14.0 months vs 11.2 months for standard treatment alone, based on interim analysis. This overall survival benefit was confirmed in an exploratory updated analysis.
  • Radium-223 dichloride binds with minerals in the bone to deliver radiation directly to bone tumors, which has a sparing effect on surrounding normal tissues. Tolerability is very good with minimal myelosuppression. During clinical trials, the most commonly reported adverse effects of radium-233 dichloride were nausea; diarrhea; vomiting; and swelling of the leg, ankle, or foot.

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