Posted by Michael Wonder on 29 Jan 2020
Janssen announces European Commission approval for expanded use of Erleada (apalutamide) for treatment of patients with metastatic hormone-sensitive prostate cancer
29 January 2020 - Latest approval for apalutamide could benefit a population of more than 100,000 people living with mHSPC across Europe.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted marketing authorisation for the expanded use of Erleada (apalutamide) to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
The EC approval is based on data from the Phase 3 TITAN study, which assessed the addition of apalutamide to ADT in a broad range of patients with mHSPC, regardless of disease volume, prior treatment with docetaxel or staging at initial diagnosis.
