Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

DRUG NEWS
(Updated June 14, 2019)

The FDA has approved the following drugs:
  • Kanjinti (trastuzumab-anns) intravenous injection as a biosimilar to Herceptin (trastuzumab) to treat HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Risks include cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.
  • Nucala (mepolizumab) subcutaneous injection in 2 new dosage forms, an autoinjector and a prefilled syringe, for self-administration outside of a clinical setting. Nucala is approved for maintenance treatment of severe eosinophilic asthma and for eosinophilic granulomatosis with polyangiitis.
  • Polivy (polatuzumab vedotin-piiq) intravenous injection in combination with bendamustine and a rituximab product to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, after at least 2 prior therapies. Accelerated approval was granted for this indication based on complete response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The FDA has approved the following new indications:
  • Emgality (galcanezumab-gnlm) subcutaneous injection to treat episodic cluster headache in adults. Emgality is also approved to prevent migraines in adults.
The FDA has approved the following expanded indications:
  • Emflaza (deflazacort) oral tablets and oral suspension to treat Duchenne muscular dystrophy (DMD) in patients 2 years and older. Emflaza was previously approved for DMD in patients 5 years and older.
  • Keytruda (pembrolizumab) intravenous injection, two expanded indications, for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) (in combination with platinum and fluorouracil), and as a single agent for the first-line treatment of patients with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1 (Combined Positive Score at least 1). Keytruda was previously approved as a single agent to treat patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 


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