"Global approval doesn't mean Australia approval. Government needs a new way of valuing the benefit of therapies that are a one-off cure differently than other drugs."
President Donald Trump has officially nominated Stephen Hahn to the position of FDA commissioner, a position held on an interim basis by Ned Sharpless since April. Hahn has held the position of CEO of the MD Anderson Cancer Center in Houston since May 2018.
The oncology field pioneered adaptive trial designs through efforts such as I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2), Puma Biotechnology Inc.’s phase II study of the pan-HER tyrosine kinase inhibitor neratinib (Nerlynx) as neoadjuvant therapy in metastatic breast cancer, and the ongoing multidrug, biomarker-driven
non-small-cell lung cancer trial known as Lung-MAP.