Janssen has chalked up a significant win in the European market following a ruling on its prostate cancer drug Zytiga (abiraterone acetate), receiving the go-ahead to add an earlier stage of metastatic prostate cancer to the drug’s label.
Initially the once daily oral drug was approved in combination with predinson/prednisolone for the treatment of metastatic castration-resistance prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT and in patients where chemotherapy is not yet clinically indicated.
It was also originally approved for the same indication but in patients whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
However, the European Commission’s decision has extended Zytiga’s indication to include the treatment of newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).
Dr Ivo Winiger-Candolfi, oncology solid tumour therapy area lead, Janssen EMEA, said: “This EC approval is a major step forward for men living with prostate cancer across Europe and offers patients with newly-diagnosed high-risk mHSPC a new treatment option.”
Prostate cancer is the most common form of cancer in men throughout Europe and according to the Johnson and Johnson pharma group, patients with mHSPC, particularly with high-risk characteristics, have a poor prognosis.
Dr Winiger-Candolfi added: “We are encouraged by the data we have seen to date and remain committed to transforming outcomes for prostate cancer patients.
The approval from the EU regulators follows a recommendation from the Committee for Medical Products for Human Use (CHMP), which was based on the positive results of Janssen’s LATITUDE study.