Caris Life Sciences announced a partnership with Debiopharm International SA for the development of a companion diagnostic test using MI Transcriptome, a Whole Transcriptome Sequencing assay for mRNA analysis.
FDA has approved a tumor-treating fields device in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, or metastatic malignant pleural mesothelioma.
FDA has approved Piqray (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
FDA approved lenalidomide (Revlimid) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.
FDA approved the addition of overall survival data in labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test.
After discussions with the FDA, Oncopeptides AB has initiated the preparation for submitting a New Drug Application for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma.
FDA has approved Venclexta (venetoclax) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
FDA approved Cyramza (ramucirumab), sponsored by Eli Lilly, as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥ 400 ng/mL and have been previously treated with sorafenib.
FDA has approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.
GE Healthcare and Indi Molecular Inc. announced plans to develop immune cell-targeted Positron-Emission Tomography tracer candidates, based on Indi Molecular's proprietary Protein Catalyzed Capture technology.
