FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated NSCLC

Clinical Trials & Tribulations

Drugs & Targets

FDA grants Breakthrough Therapy designation for daraxonrasib in pancreatic cancer

FDA has granted Breakthrough Therapy Designation to daraxonrasib, a RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations.

June 27, 2025

Vol.51 No.25

Optimizing dosing of expensive and toxic oncology drugs: Making America healthier

There is general agreement that the United States spends too much on health care, especially on pharmaceuticals. But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half. Simply stated, cost is the product of (price per unit times the number of units purchased).

By Mark J. Ratain, David A. Hyman, Jill E. Feldman, Beth R. Jacobson and Allen S. Lichter

Cancer Policy

FDA to issue “national priority vouchers” to companies supporting U.S. interests

A new FDA voucher program will aim to accelerate review time for applications that are deemed to be advancing U.S. “national priorities.”

Cancer Policy

Vinay Prasad named chief medical and scientific officer at FDA

Vinay Prasad, a MAHA-aligned hematologist-oncologist with an avid cyber following, who was named director of the FDA Center for Biologics Evaluation and Research in early May (The Cancer Letter, May 9, 2025), has now been also appointed chief medical and science officer at FDA, according to an internal memo obtained by The Cancer Letter.

Cancer Policy

FDA halts new clinical trials that export Americans’ cells to foreign labs in hostile countries

FDA has announced that the agency will begin immediately reviewing all new clinical trials that include shipping American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion” back into American patients.