FDA Expands Indication of Metastatic Breast Cancer Treatment to Include Male Patients – Drug for nerve pain boosts high for opioid abusers.

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FDA Expands Indication of Metastatic Breast Cancer Treatment to Include Male Patients – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have extended the indication of palbociclib (Ibrance, Pfizer) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

The indication’s expansion for palbociclib to include male patients is based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with the drug is consistent with the safety profile in women treated with this medication, according to Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

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