To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
The FDA Oncologic Drugs Advisory Committee July 17 recommended against approval of a Blenrep-based regimen for the treatment of relapsed or refractory multiple myeloma, citing unacceptable rates of ocular toxicity and overall poor tolerability of the drug.
