EMA’s CHMP Recommends Zytiga Combo Therapy for Certain Early-stage Prostate Cancer Patients

EMA’s CHMP Recommends Zytiga Combo Therapy for Certain Early-stage Prostate Cancer Patients
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended that the prostate cancer combo therapy Zytiga (abiraterone acetate) plus prednisone/prednisolone in combination with androgen deprivation therapy (ADT) be approved in the European Union for the treatment of early stage prostate cancer, Janssen announced. The recommendation is for newly diagnosed, high-risk, metastatic hormone-sensitive prostate cancer (mHSPC) patients. The European Commission, which has the authority to approve or deny this new indication, will review the CHMP's recommendation. The EMA panel's decision is supported by results from the LATITUDE Phase 3 study (NCT01715285), designed to determine if newly diagnosed men (within the previous three months) with mHSPC and high-risk prognostic factors benefit from adding Zytiga and low-dose prednisone to ADT, compared to ADT alone. The trial enrolled 1,199 patients and was conducted at 235 sites in 34 countries in Canada, Latin America, Europe, and the Asia-Pacific region. After a median follow-up of 30.4 months, patients receiving Zytiga and ADT had a significantly higher overall survival than those receiving ADT alone. They also lived significantly longer without tumor progression, assessed radiographically. The safety profile of androgen-deprivation therapy combined with Zytiga and prednisone was similar to previous studies with metastatic castration-resistant prostate cancer (mCRPC) patients. The results of this interim analysis, “
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