On Sept. 14, FDA approved updated labeling for Temodar (temozolomide) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.
Flatiron Health and FDA’s Oncology Center of Excellence renewed their collaboration to jointly develop and implement specific research projects to advance the use of real-world data and explore the potential strengths and limitations of using real-world evidence for regulatory purposes. The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.
Pierre Fabre Laboratories, the French pharmaceutical and dermo-cosmetic company, announced the acquisition of Vertical Bio AG, a developer of novel cancer therapies.
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.
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.
The European Commission approved Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
The European Commission approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage 2B or 2C melanoma who have undergone complete resection, based upon results from the CheckMate-76K trial.
