FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
FDA has granted accelerated approval to linvoseltamab-gcpt, trade name Lynozyfic, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated
FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary to ensure that the benefits of these CAR T-cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system of complying with the REMS.
Jacqueline Corrigan-Curay, the acting director of the Center for Drug Evaluation and Research wrote in an email to colleagues that she will be retiring from the agency in July.
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.
