REGULATORY CORNER

In this blog, I will be referencing data in the public domain to compare and contrast the studies submitted to FDA to support label expansions for two marketed products and the similarities and differences in the FDA review and outcomes. By way of disclosure, PROMETRIKA has not worked on either of the two products discussed and all information presented is in the public domain (the October 5, 2023 Oncologic Drugs Advisory Committee (ODAC) FDA slides and ODAC vote for the first and the April 1, 2022 Clinical Review and Evaluation and Statistical Review for the second).