The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending dostarlimab as monotherapy in women with mismatch repair deficient/microsatellite instability-high recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen.
Novartis said it has closed the in-licensing of tislelizumab from BeiGene, Ltd. in North America, Europe and Japan. Tislelizumab is a uniquely designed anti-PD-1 antibody, specifically engineered to minimize binding to FcyR on macrophages, that is approved in China for certain patients with non-small cell lung cancer, classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
FDA has approved Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.
Biocept Inc. and Protean BioDiagnostics Inc. are collaborating to research the ability of Biocept's Target Selector molecular assay to determine EGFR status in non-small cell lung cancer patients.
Researchers at Indiana University School of Medicine and IU Simon Comprehensive Cancer Center have developed a novel antibody-drug conjugate for treating triple negative breast cancer.
FDA has approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
Exact Sciences Corp. has entered into an agreement to acquire Ashion Analytics from The Translational Genomics Research Institute, an affiliate of City of Hope.
FDA has granted accelerated approval to Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications:
FDA has approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.
