Regulatory requirements for conditional marketing authorizations (CMAs) are “evolving” and more complicated than in the past in terms of demonstrating a product’s major therapeutic advantage (MTA). Regulators hold differing views on criteria for CMAs, according to EU officials who spoke at a panel on conditional approval of cancer drugs at DIA Europe 2024 on 13 March.
The EU has authorized more than 55 products with CMA since the launch of the pathway in 2006; the conditional pathway was established to expedite access to new medicines in areas of unmet or serious need by allowing sponsors to market a product based on incomplete clinical data until the sponsor is able to provide more comprehensive data.
Filip Josephson of the Swedish Medical Products Agency (MPA) said that most CMAs are for oncology treatments that are late or last-line treatment and where no satisfactory treatment options exist. Josephson represents MPA at the EMA’s Committee for Human Medicinal Products (CHMP), and is a rapporteur for infectious disease, oncology, and onco-hematology products…
