Pcn19 Age Disparities in Inflammatory Breast Cancer Initial Surgical Resection and Mortality: An Analysis of 1991-2015 Seer Data

Abstract

were included. FDA designation, approval date and pivotal trial data were acquired from the Drugs@FDA index. Results: For 29 of 31 drug/indication combinations investigated, those launched second or later were approved with trial data equal to or more mature (superior endpoint or later trial phase) than first drugs to market. Early trial data (Phase I or II) and immature endpoints (objective response rate) were more likely to be submitted for launches in indications with a higher unmet need. Indications with a 5-year survival rate , 20% were more likely to submit immature data (9/15, 60%) than indications with a 5-year survival rate .20% (6/13, 46%), (one drug was excluded from analysis). Phase I data were only submitted for first-tomarket drugs (N=2) with 5-year survival rates of ,20%. Conclusions: In this sample, 9/15 oncology products launched in indications with low (,20%) 5-year survival were approved with immature data for FDA approval compared to 6/13 in indications with 5-year survival rates .20%. This has implications for strategies by pharmaceutical companies in terms of evidence generation and launch sequencing in the US market and the resulting access to oncology drugs for high unmet needs.