The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II variation to the European Medicines Agency (EMA) seeking approval of ERLEADA®(apalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), regardless of extent of disease or prior docetaxel treatment history.
BEERSE, BELGIUM, 4th June, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II variation to the European Medicines Agency (EMA) seeking approval of ERLEADA®(apalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), regardless of extent of disease or prior docetaxel treatment history. The submission is based on findings from the Phase 3 TITAN study which were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published online in The New England Journal of Medicine. i,ii
The submission to the EMA follows the submission of supplemental registration dossiers to the U.S. Food and Drug Administration (FDA) on 29th April 2019 and to the Japanese Ministry of Health, Labour and Welfare (MHLW) on 31stMay 2019 seeking approval of a new indication for apalutamide for the treatment of patients with mHSPC.[iii],[iv]
“Today’s application seeking to expand the approval of apalutamide for the treatment of patients with mHSPC marks an important step in our continued focus and commitment to bring innovative medicines forward in the treatment of prostate cancer,” said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. “We look forward to working with the EMA to expand access to this next-generation androgen receptor inhibitor for those patients who may benefit from this treatment in the future.”
For any further questions please don’t hesitate to contact Hannah Gazzard at HannahGazzard@OpenHealthGroup.
