FDA has cleared the B·R·A·H·M·S CgA II Kryptor immunoassay to assess tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.Â
FDA has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer with cMET overexpression.Â
FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk, locally advanced cervical cancer.Â
FDA is accepting applications for its Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01). This program is administered by the FDA’s Office of Orphan Products Development.Â
FDA granted accelerated approval to Elrexfio (elranatamab-bcmm), 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.
FDA has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia.
FDA approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions.
FDA granted 510(k) clearance to AION Biosystems’s iTempShield, a skin-wearable device supported by cloud-based software and proprietary algorithms enables continuous body temperature monitoring.Â
FDA accepted a supplemental New Drug Application and granted Priority Review for Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1-mutated relapsed or refractory myelodysplastic syndromes. If approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset.
FDA granted accelerated approval to Talvey (talquetamab-tgvs) 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.
