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.

(Updated April 10, 2018)

The FDA has approved the following expanded indications:
 
  • Blincyto (blinatumomab) intravenous injection to treat B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1% in adults and children. Blincyto is also approved to treat relapsed or refractory B-cell precursor ALL in adults and children. 
  • Emend (fosaprepitant) intravenous injection to prevent, in adults and pediatric patients 6 months and older, acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin; and to prevent delayed nausea and vomiting following initial and repeat courses of moderately emetogenic cancer chemotherapy. Emend was previously approved in adults only.
  • Leukine (sargramostim) subcutaneous or intravenous injection to improve survival in adult and pediatric patients, ages birth to 17 years, who were acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). Leukine is also approved to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections after induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia; to mobilize hematopoietic progenitor cells into peripheral blood for collection by leukapheresis in adult patients undergoing autologous transplantation; to accelerate myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years and older; to accelerate myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years and older; and to treat delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years and older.
  • Rubraca (rucaparib) oral tablets as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who experience complete or partial response to platinum-based chemotherapy, and to treat adult patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 2 or more chemotherapies. Rubraca was previously approved for advanced ovarian cancer.
 

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