FDA unveils plan to eliminate orphan designation backlog

The Directors: Mark Evers and Steven Libutti on riding out the tempest—and maintaining research momentum
As oncology braces for funding, Medicaid cuts, these two directors tell young investigators not to panic

“I don’t think any good cancer center director would be worth their weight in salt if they weren’t worried about something at night,” said Mark Evers, director of University of Kentucky Markey Cancer Center.

July 18, 2025

Vol.51 No.28

By Paul Goldberg and Katie Goldberg

Regulatory News

ODAC nixes GSK’s Blenrep myeloma regimens, citing ocular toxicity, dosing, applicability to U.S. population

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.

July 18, 2025

Vol.51 No.28

By Jacquelyn Cobb and Sara Willa Ernst

Imaging’s ride to the bottom in clinical trials—and why it matters now

In cancer care, imaging has become a marvel of modern medicine. Advances in scanner technology, reconstruction algorithms, contrast agents, and diagnostic protocols have radically improved our ability to detect, track, and understand disease. Clinically, imaging is fast, accurate, and central to decision-making.

July 18, 2025

Vol.51 No.28

By Jeff Sorenson