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.
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.
NIH has announced that it will no longer be issuing Notices of Funding Opportunities exclusively supporting animal models.
FDA has granted Priority Review to TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.
In a move advertised as being in line with FDA’s goal of “radical transparency,” the agency July 10 announced the publication of more than 200 complete response letters.
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.
