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, “Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer” appeared in The New England Journal of Medicine.
“As shown by the results from the LATITUDE study, adding abiraterone acetate [Zytiga] plus prednisone / prednisolone to ADT alone significantly improves overall survival and radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer and high-risk features in comparison to treating patients with ADT alone, where median survival is currently less than three years,” Prof. Karim Fizazi, principal investigator of the LATITUDE trial and head of the Medical Oncology Department at Institute Gustave Roussy, said in a press release.
“Today’s decision means we are one step forward in ensuring mHSPC men across Europe may be able to benefit from this treatment soon,” he added.
The European Commission has already approved the combination of Zytiga plus prednisone / prednisolone as treatment for adult men with mCRPC who have no or mild symptoms and failed to respond to ADT, and for whom chemotherapy is not indicated.
The therapy is also approved for adults whose disease has progressed or who received a Taxotere (docetaxel)-based chemotherapy regimen.
“We are very pleased with the CHMP’s decision, which recommends abiraterone acetate plus prednisone / prednisolone in combination with ADT for use in adult patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer,” said Dr. Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead at Janssen Europe, Middle East and Africa.
“Janssen Oncology has played a significant role in transforming the way prostate cancer is treated so far and aims to continue this progress,” he added.