FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.
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.
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).
A new FDA voucher program will aim to accelerate review time for applications that are deemed to be advancing U.S. “national priorities.”
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.
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.
Johnson & Johnson announced on June 15 new results from the phase II RedirecTT-1 study evaluating the investigational combination of Talvey (talquetamab-tgvs), the first U.S. FDA-approved GPRC5D-directed bispecific antibody, and Tecvayli (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody.
FDA has approved Zusduri as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
FDA has approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
HHS Secretary Robert Kennedy Jr. asserted that under his leadership, FDA will “end the war” against alternative medicine.
