New FDA oncology small molecule drugs approvals in 2020: Mechanism of action and clinical applications.

Abstract In 2020, fifty-three new drugs, including forty small-molecules (thirty-six new chemical entities and four new diagnostic agents) and thirteen biologic drugs were approved by the U.S. Food and Drug Administration (FDA). This year, small-molecules continue to play a role in innovative treatments representing around 75% of all drugs accepted by FDA. The dominant therapeutic area was oncology, accounting for twenty-three new approvals, including thirteen new chemical entities, four new diagnostic agents, and thirteen biologic drugs. Recognizing the importance of small-molecules on cancer treatment, this review aims to provide an overview regarding the clinical applications and mechanism of action of the thirteen new small-molecules (excluding new diagnostic agents) approved by FDA in 2020.