FDA July 23 extended the review period for the Biologics License Application for Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
FDA issued a Complete Response Letter regarding the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
FDA granted Breakthrough Therapy designation to elironrasib, a RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
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.
