European regulators are allowing earlier use of Janssen’s Zytiga in the treatment pathway for metastatic prostate cancer.
Zytiga (abiraterone) plus prednisone/prednisolone has been approved to treat newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
The drug is already available in Europe for metastatic castration-resistant prostate cancer (mCRPC) in adults who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated and in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The new approval is “a major step forward for men living with prostate cancer across Europe and offers patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer a new treatment option,” said Dr Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen Europe, Middle East and Africa.
“We are encouraged by the data we have seen to date and remain committed to transforming outcomes for prostate cancer patients”.
The decision follows backing from the Committee for Medical Products for Human Use, which recommended expanding the drug’s approval after data from the multinational, multicentre, randomised, double-blind, placebo-controlled Phase III study LATITUDE showed that men taking abiraterone had a 38 percent lower risk of death than those who received placebo.
Zytiga was also associated with a 53 percent lower risk of the cancer worsening and resulted in cancer growth being delayed by a median of 18.2 months.