CHMP recommends approval of expansion of use of Erleada in metastatic hormone-sensitive prostate cancer.- Janssen Biotech

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a Positive Opinion recommending approval for expanding the 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 CHMP�s Positive Opinion will now be reviewed by the European Commission (EC), which has the authority to grant approval for the new use of apalutamide.

The Positive Opinion is based on data from the Phase III TITAN study, which assessed the addition of apalutamide to ADT � the current standard of care in mHSPC � in a broad range of patients with mHSPC, regardless of disease volume, prior treatment with docetaxel or staging at initial diagnosis. The dual primary endpoints of the study were overall survival (OS) and radiographic progression-free survival (rPFS). Apalutamide plus ADT significantly improved OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95% CI, 0.51-0.89; p=0.0053). In both study arms, median OS was not reached. Apalutamide plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent reduction in risk of radiographic progression or death compared to placebo plus ADT (HR=0.48; 95% CI, 0.39-0.60; p<0.0001). the median rpfs was 22.1 months for placebo plus adt and not reached for apalutamide plus adt. the two-year os rates after a median follow up of 22.7 months were 82 percent for apalutamide plus adt compared to 74 percent for placebo plus adt. these results were presented at the 2019 american society of clinical oncology asco annual meeting and simultaneously published online in the new england journal of medicine.>

The safety profiles for apalutamide plus ADT, versus placebo plus ADT, were similar with 42 percent versus 41 percent of Grade 3/4 adverse events (AEs) observed respectively. The most common Grade ?3 AEs for apalutamide plus ADT versus placebo plus ADT were hypertension (8.4 percent vs. 9.1 percent) and skin rash (6.3 percent vs. 0.6 percent). Treatment discontinuation due to AEs was 8 percent in the apalutamide arm compared to 5 percent in the placebo arm.