The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a second indication for Sarclisa (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
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.
The National Cancer Institute approved the following clinical research studies last month.
The American Association for Cancer Research and The Mark Foundation for Cancer Research have awarded five grants to support innovative research focused on understanding the influence of the biology of the patient on the genesis, development, treatment, and survivorship of cancer.
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.
An NCI study demonstrated that people who have had evidence of a prior infection with SARS-CoV-2, the virus that causes COVID-19, appear to be well protected against being reinfected with the virus, at least for a few months.
