Janssen has announced that the European Commission (EC) has granted marketing authorisation for the expanded use of Erleada (apalutamide), to now include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
The Commission revealed that the extension is based on data from the Phase III TITAN study, which assessed the addition of the drug to ADT in a broad range of patients with mHSPC.
Data from the trial demonstrated that when combined, Erleada and ADT significantly improved overall survival compared to placebo with ADT, with a 33% reduction in the risk of death. It was also found to significantly improve radiographic progression-free survival compared to placebo plus ADT, with a 52% reduction in risk of radiographic progression or death compared to placebo.
The extended approval marks a “significant advancement for those living with mHSPC,” commented professor Dr Axel S Merseburger, before going on to say: “In prostate cancer treatment, our primary goal is always to delay progression of disease and prolong survival, to ensure the best possible outcomes for patients.
“Today’s news is therefore an encouraging development for patients within Europe, for whom the importance of an additional treatment option that can both delay progression and extend survival cannot be underestimated.”
The approval could benefit a population of more than 100,000 people living with the certain type of prostate cancer across Europe, as although the majority of mHSPC patients can have an initial response, ADT alone is not enough to delay progression and extend survival in mHSPC.