FDA has granted accelerated approval to Trodelvy (sacituzumab govitecan) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
FDA has authorized marketing of the GI Genius, the first device that uses artificial intelligence based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.
Sacituzumab govitecan was granted regular FDA approval for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
FDA has approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks for cetuximab for patients with K-Ras wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.
In updated guidelines for breast cancer, the National Comprehensive Cancer Network recognized the Oncotype DX Breast Recurrence Score test as the only test that can be used for prediction of chemotherapy benefit in early-stage breast cancer patients with one to three positive axillary lymph nodes, including micro metastases.
MD Anderson Cancer Center and TriSalus Life Sciences are collaborating to evaluate the treatment of tumors of the pancreas and liver by integrating interventional delivery of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in combination with checkpoint inhibition immunotherapy.
FDA has approved Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
FDA has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Futibatinib (TAS-120), a covalently-binding FGFR inhibitor, has received Breakthrough Therapy designation from FDA for patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions.
FDA has issued a Complete Response Letter regarding Merck’s supplemental Biologics License Application seeking approval for Keytruda, Merck’s company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery.
