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NCCN: What People with Cancer and their Caregivers Need to Know about CAR T-Cell Therapy (PRNewswire) - Jul 1, 2020 - "The National Comprehensive Cancer Network® (NCCN®)...announced the completion of the new NCCN Guidelines for Patients®: Immunotherapy Side Effects series, with the publication of a book focused on chimeric antigen receptor (CAR) T-cell therapy...'patients are often surprised to learn that the single CAR T infusion includes a 28-day monitoring period'...During that monitoring period, the health care team is primarily watching for two things: cytokine release syndrome (CRS)—in which immune cells affected by the treatment release proteins called cytokines into the blood, stimulating an intense systemic inflammatory response—and immune effector cell-associated neurotoxicity syndrome (ICANS)—a range of neurological side effects. Both CRS and ICANS are generally reversible if treated promptly."pralsetinib (BLU-667) / Blueprint MedicinesBlueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers (PRNewswire) - Jul 1, 2020 - "Blueprint Medicines Corporation…announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pralsetinib for the treatment of patients with advanced or metastatic RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers."ISA101 / ISA PharmaISA Pharmaceuticals Receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer (PRNewswire) - Jul 1, 2020 - "ISA Pharmaceuticals...today announced that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer....ISA101b is protected by several patent families covering different aspects of the vaccine product. Patent protection of the vaccine product is expected until at least 2037."
