XTANDI® (enzalutamide) receives expanded approval from FDA for treatment of metastatic castration-resistant prostate cancer
FLINT, Mich., — Sept. 30, 2014 — Diplomat, a nationally recognized specialty pharmacy, announced that XTANDI® has been granted an expanded approval by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic castration-resistant prostate cancer (CRPC). The new indication allows for the use of XTANDI in patients who have not received chemotherapy.
XTANDI is an oral, once-daily androgen receptor inhibitor capsule now available for patients in all stages of disease progression. The new indication has been approved based on the results of the Phase 3 PREVAIL clinical trial. In the trial, men receiving XTANDI and treatment to lower testosterone exhibited a statistically significant improvement — in both overall survival and delayed time to radiographic progression or death — as compared to placebo and treatment to lower testosterone. XTANDI was also shown to increase the amount of time before initiation of chemotherapy was deemed necessary.
Metastatic CRPC is cancer that has spread beyond the prostate gland and has progressed in spite of treatment to lower testosterone.
Diplomat is a member of a limited panel of specialty pharmacies able to dispense XTANDI, which was first approved by the FDA in August 2012.
For full prescribing information, visit https://www.xtandihcp.com/
Diplomat serves patients and physicians in all 50 states as a nationally recognized specialty pharmacy. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with complex chronic diseases, including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: “Take good care of patients, and the rest falls into place.” Today, that tradition continues – always focused on improving patient care and clinical adherence. For more information visit www.diplomat.is. Follow us on Twitter and LinkedIn and like us on Facebook.
Gary Rice, Diplomat
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