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 July 8, 2019)

The FDA has approved the following drugs:
  • Xembify (immune globulin human-klhw) subcutaneous injection to treat primary humoral immunodeficiency in patients 2 years and older. Xembify is expected to be released at the end of 2019.
  • Xpovio (selinexor) oral tablets in combination with dexamethasone to treat adult patients with relapsed refractory multiple myeloma who have received at least 4 previous therapies and whose disease is refractory to several other forms of treatment, including at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody. This indication was granted accelerated approval based on response rate; continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 
  • Zirabev (bevacizumab-bvzr) intravenous injection as a biosimilar to Avastin (bevacizumab) to treat metastatic colorectal cancer, combined with intravenous fluorouracil-based chemotherapy for first- or second-line treatment; and metastatic colorectal cancer, combined with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product–containing regimen.
The FDA has approved the following new indications:
  • Doptelet (avatrombopag) oral tablets to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had a poor response to a previous treatment. Doptelet is also indicated to treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
  • Dupixent (dupilumab) subcutaneous injection as an add-on maintenance treatment in adults with insufficiently controlled chronic rhinosinusitis with nasal polyposis. Dupixent is also indicated for atopic dermatitis and asthma in patients 12 years and older.
  • Soliris (eculizumab) intravenous injection to treat neuromyelitis optica spectrum disorder in adult patients who are AQP4 antibody positive. Soliris is also indicated to treat atypical hemolytic uremic syndrome, generalized myasthenia gravis, and paroxysmal nocturnal hemoglobinuria. One major risk is serious meningococcal infections.
The FDA has approved the following expanded indications:
  • Darzalex (daratumumab) intravenous injection in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplant. Darzalex is also approved for other combinations to treat multiple myeloma.
  • Thiola (tiopronin) oral tablets to include, in combination with high fluid intake, alkali, and diet modification, the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria who are not responsive to these measures alone. This indication was previously approved for patients 9 years and older. 

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