Pathways of drug development in Oncology specifically looking into time and nature of initial FDA approval, summarised by Tanja Obradovic

Tanja Obradovic shared a post on LinkedIn:

“Insightful article just published by authors from National Pharmaceutical Council discusses pathways of drug development in Oncology specifically looking into time and nature of initial FDA approval and subsequent label expansions by additional approvals in 2008-2018 period.

Few findings stand out. Drugs typically start with first approval in the late stage disease with subsequent expansion into front line. Approximately half were approved for multiple types of new combinations over the course of their development. Drugs more commonly received approval of new combinations, either after approval in combination with a different drug or as monotherapy, than as monotherapy after initial approval in combination although very few drugs started with combination to truly gauge impact of this pathway.

Analysis of possible impact of Inflation Reduction Act (IRA) was commented in light of possible delay of launch and limitations of label expansion development. However, this analysis did not account for impact of initial approved indication size characterizing development. This aspect is of critical influence as drugs entering in smaller indications due to need to rapid development have strong incentive to expand into areas of larger medical need.

Compared to 2008-2018 period current landscape of approved drugs has substantial presence of immunotherapy especially in large indications and therefore strategy of novel development has to account for this very different state.
Informative read and intriguing to see future deeper analysis with more parameters as well as comparison with actual impact of IRA.”

Subsequent Indications in Oncology Drugs: Pathways, Timelines, and the Inflation Reduction Act

Authors: Julie A. Patterson, James Motyka, Rayan Salih, Robert Nordyke, John M. O’Brien & Jonathan D. Campbell 

Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.