FDA approved Biocon Biologics Ltd’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab).Â
Credit: NCI/Linda BartlettIn an oral history conducted by FDA in September 2013, Andrew C. von Eschenbach recounted his eight-month stint in a dual role as both FDA acting commissioner and NCI director.Â
FDA approved AstraZeneca’s durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer.
The U.S. Department of Health and Human Services announced that it is making sweeping revisions by cutting personnel, centralizing functions, and consolidating divisions.Â
FDA approved cabozantinib (Cabometyx) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.
FDA approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), a next-generation PSMA-PET imaging agent for prostate cancer.
FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
FDA granted Orphan Drug designation to rhenium obisbemeda (186Re) for the treatment of leptomeningeal metastases in patients with lung cancer.
B-cell acute lymphoblastic leukemia is a common type of ALL in adults.Â
The phase III VERIFY trial, in which phlebotomy-dependent patients with polycythemia vera were randomized to treatment with either rusfertide (PTG-300) or placebo, as an add-on to standard of care treatment, met its primary endpoint of proportion of patients achieving response.Â
