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All Oncology News

Sesen Bio met with the FDA to discuss questions related to the Chemistry, Manufacturing, and Controls that were raised in the complete response letter previously issued by the regulatory agency regarding the biologics license application for Vicineum as a potential treatment for patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.

Erin Roesch, MD

Standard chemotherapy has historically been the mainstay of treatment for patients with diagnoses of early-stage TNBC, but there remains an unmet need to identify novel therapies that improve outcomes and, equally important, to discern which patients may benefit from a given treatment.

The FDA has accepted for review a biologics license application for the use of toripalimab in combination with gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and for use as a single agent in the second- or later-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma following platinum-containing chemotherapy.