FDA granted accelerated approval to Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, in combination with the chemotherapy bendamustine and rituximab product, to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
FDA has approved Merck's Keytruda as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score ≥1) or in combination with platinum and fluorouracil for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
FDA has approved Agilent Technologies Inc.'s PD-L1 IHC 22C3 pharmDx assay for expanded use.
Cofactor Genomics said it has become a member of the Foundation for NIH Biomarkers Consortium with the goal of advancing the adoption of multidimensional biomarkers in cancer and immune-related diseases.
Genmab A/S announced FDA granted a Priority Review for the supplemental Biologics License Application for the use of daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant.
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.