(263) New Advances in US FDA Approved Oncology Drugs from 2015-2023

Objective : The objective of this study is to conduct a systematic review of these recently approved oncology drugs from 2015-2023, and analyze recent approval trends in the cancer chemotherapy arena.

Methods: This data analysis was conducted using new drug approval online resources provided by the US FDA’s Center for Drug Evaluation and Research (CDER). Drug information database Lexicomp and product prescribing information were also used in this study. Physicochemical properties such as molecular weight, hydrogen bond acceptor, hydrogen bond donor, LogP, and polar surface area (PSA) were obtained from ChemSpider and Chemfinder database.

Results: From 2015-2023, the US FDA has approved 416 new chemical entity and therapeutic biologic drugs with a total of 118 new oncology drug approvals, representing over 28% of all new drugs approved in the last nine years. Among these new oncology drugs, about 63% of them are small molecules and 32% are biologic monoclonal antibodies. In addition, about 47% of them (55) belong to kinase inhibitors; detailed drug characteristics including molecular weight, hydrogen bond acceptors and donors, PSA, and logP will be analyzed and presented. Nine new antibody-drug conjugates (ADC) were also approved during this period. Furthermore, the top 3 approved cancer categories are hematologic/blood cancer (33%), respiratory/lung cancer (16%), and genitourinary/gynecology related cancer (12%).

Conclusions: In the last decade, significant medicine advances have been made with over 400 total new drug approvals by the US FDA. Among those, oncology has the most drug approvals with 118 new drugs, representing > 28% of total new drug approvals. Notably, 33 new oncology drugs belong to fluoro-pharmaceuticals.