December 15, 2014
An article published in the Annals of Oncology discusses clinical trial endpoints acceptable to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to approve oncology drugs. The authors highlight that acceptance of surrogate endpoints is essential to accelerate drug approval. However, following guideline revisions in Japan, the number of accepted surrogate endpoints has decreased. While Japan’s regulatory system proposes many expedited programs, including orphan drug designation, priority review, public knowledge-based application and a special committee on unapproved drugs, the country is lagging behind the US and the EU in terms of drug approvals. The authors believe that an accelerated approval program and surrogate endpoint discussions are necessary to bring oncology drugs to patients faster..