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    FDA approves label update for advanced PCa treatment

    The FDA has approved a label update for abiraterone acetate (ZYTIGA) plus prednisone following publication of phase III trial data showing the combination therapy extended median overall survival compared to placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC).

    READ: European data on PCa assay comparable to U.S. findings

    Data from the COU-AA-302 phase III trial were published in The Lancet Oncology (2015; 16:152-60). The study of the two regimens in 1,088 asymptomatic to mildly symptomatic men found that those receiving prednisone (5 mg, twice daily) plus abiraterone acetate (1,000 mg, once daily) experienced a median overall survival of 34.7 months (95% CI 32.7-36.8) compared to 30.3 months (95% CI 28.7-33.3) in men receiving a prednisone-placebo combination (p=.003).

    Endpoints for the trial were radiographic progression-free survival and overall survival analyzed in the intention-to-treat population. Some 365 patients (67%) in the abiraterone group and 435 (80%) in the prednisone plus placebo alone group were given subsequent treatment with one or more approved chemotherapies.

    During the course of the trial, 238 (44%) of the men receiving prednisone alone were moved to the combination therapy as an aspect of the crossover protocol (93 patients) or as a subsequent treatment (145 patients). The trial's median follow-up was 49.2 months.

    The most common grade 3-4 side effects were cardiac disorders in 8% of the abiraterone group versus 4% of the prednisone-alone group, increased alanine aminotransferase in 6% of the abiraterone group compared to 1% in prednisone group, and hypertension in 5% of the abiraterone group versus 3% in the prednisone group.

    "The statistically significant improvement in overall survival demonstrated in the final analysis and resulting label update help affirm the established efficacy, safety, and tolerability that physicians treating men with metastatic castration-resistant prostate cancer have seen with ZYTIGA," said lead investigator Charles J. Ryan, MD, of the University of California, San Francisco in a press release from Janssen Research & Development, LLC.

    NEXT: COU-AA-302 data also presented at GU '15

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