Alexandra Oger1, Aimad Torqui2, Robert Kester3, Sacha Wissink2. 1. MSD Europe Inc, Clos du Lynx 5, 1200, Brussels, Belgium. alexandra.oger@merck.com. 2. MSD, Oss, The Netherlands. 3. Merck & Co., Inc., Rahway, NJ, USA.
Abstract
BACKGROUND: The oral explanation (OE) is a critical event during new marketing authorisation procedures in the European Union (EU). The primary objective of the present study was to investigate how many procedures, having an OE in front of the Committee for Medicinal Products for Human Use (CHMP), resulted in a regulatory approval for oncology products. METHODS: Procedures for new marketing authorisation applications (MAAs) and Type II variations (new indication) for oncology products with at least one OE (with or without a Scientific Advisory Group (SAG) meeting) and for which the outcome took place between 31 January 2016 to 31 January 2020 were included in the analysis. Publicly available agendas/meeting minutes and assessment reports were used to obtain information on the products. RESULTS: An OE occurred in about 20% of procedures (n = 28/150) for oncology products during the review period. The majority of procedures having an OE (61%), with or without any SAG meeting, led to MAA/Type II variation approval in the Centralised Procedure. It was also observed that in 41% of the cases a successful outcome was contingent upon willingness of the applicant to restrict the indication. CONCLUSION: A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.
BACKGROUND: The oral explanation (OE) is a critical event during new marketing authorisation procedures in the European Union (EU). The primary objective of the present study was to investigate how many procedures, having an OE in front of the Committee for Medicinal Products for Human Use (CHMP), resulted in a regulatory approval for oncology products. METHODS: Procedures for new marketing authorisation applications (MAAs) and Type II variations (new indication) for oncology products with at least one OE (with or without a Scientific Advisory Group (SAG) meeting) and for which the outcome took place between 31 January 2016 to 31 January 2020 were included in the analysis. Publicly available agendas/meeting minutes and assessment reports were used to obtain information on the products. RESULTS: An OE occurred in about 20% of procedures (n = 28/150) for oncology products during the review period. The majority of procedures having an OE (61%), with or without any SAG meeting, led to MAA/Type II variation approval in the Centralised Procedure. It was also observed that in 41% of the cases a successful outcome was contingent upon willingness of the applicant to restrict the indication. CONCLUSION: A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.