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FDA News Briefs for Thursday, November 29, 2018

November 29, 2018

These Food and Drug Administration (FDA) developments came in on Wednesday:


FDA Approves First Therapy for Lambert-Eaton Myasthenic Syndrome

The FDA has approved Firdapse (amifampridine; Catalyst Pharmaceuticals Inc.) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder of the neuromuscular junction. Firdapse is the first FDA-approved therapy specifically indicated for LEMS. More Information.


FDA Approves Drug for Relapsed or Refractory AML With FLT3 Mutation

The FDA has approved Xospata (gilteritinib; Astellas Pharma) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. The agency also expanded indications for a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay (Invivoscribe Technologies Inc.), to include use with Xospata. More Information.


First Biosimilar Approved to Treat Adults with NHL

The FDA has approved Truxima (rituximab-abbs), the first biosimilar to Rituxan (rituximab) indicated for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). Truxima is approved for use as a single agent or in combination with chemotherapy. More Information.