Noted

Technology entrepreneur Larry Ellison announced that he will give $200 million to the University of Southern California in Los Angeles to create the Lawrence J. Ellison Institute of Transformative Medicine, which will focus on cancer research. The gift will help fund the construction of a state-of-the-art building with interdisciplinary laboratories in which cancer researchers will draw upon the knowledge of experts from fields such as mathematics, physics, and engineering.

A recent study questioned the FDA's Accelerated Approval program for new cancer drugs. The analysis found that of 25 drugs approved between 2009 and 2014, 56% lacked supporting evidence aligning the surrogate measures used—including objective response rate and progression-free survival—with a survival benefit (Mayo Clin Proc 2016;91:713–25).

The NIH awarded $142 million over 5 years to the Rochester, MN–based Mayo Clinic to create a biobank for the Precision Medicine Initiative cohort program. The funds will be used to collect, store, and distribute more than 35 million biospecimens for comprehensive genomic analyses.

The FDA issued a new form for physicians to request expanded access to an investigational drug or biologic for patients who suffer from serious or life-threatening diseases and for whom no comparable or satisfactory alternative therapy or clinical trial is available. “We know that navigating this process can be challenging and time-consuming, and we are committed to reducing the procedural burdens on physicians and patients whenever possible,” said FDA Commissioner Robert Califf, MD.

Former FDA Commissioner Margaret Hamburg, MD, and Sanofi research head Elias Zerhouni, MD, called for international harmonization of drug regulations. In an editorial, they wrote that “the mosaic of regulations that govern drug development and oversight nation by nation are creating unnecessary barriers to the efficient delivery of safe, innovative, and effective treatments to patients in need” (Sci Transl Med 2016;8:338ed6).

For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/content/early/by/section.