FDA Approves a New Drug for Prostate Cancer


xofigo_378336 Image Credit: Good Search

The German drug companies Bayer and it’s development partner, Algeta have just received approval from US Food and Drug Administration (FDA) for a prostate cancer drug. Radium-223-dichloride (Xofigo) is an injection treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

The drug chemically binds to minerals in bone directly delivering radiation to bone tumors and limiting damage to surrounding tissues.

The downside is the adverse reactions to radium-223, which occurred in greater than ten percent of patients in trials. The reactions include: nausea, diarrhea, vomiting and peripheral edema. There were also hematologic laboratory abnormalities in greater than ten percent of patients in trials, including anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.

According to the Reuters report, “Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival and delay in time to first symptomatic skeletal event compared to placebo, as shown in the pivotal phase III ALSYMPCA trial,” the companies said.

 

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One thought on “FDA Approves a New Drug for Prostate Cancer

  1. Pingback: In Search of Clarity on Prostate Cancer Screening, Post-Surgical Followup, and Prediction of Long Term Remission | Pharmaceutical Intelligence

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