FDA Maintains Ongoing Efforts to Expedite Drug Approvals


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The U.S. Food and Drug Administration (FDA) is continuing its efforts to expedite oncology-hematology drug approvals. As of May 15, 2016, FDA has approved the following agents since January of this year.

  • Lenvatinib (Lenvima), in combination with everolimus (Afinitor), for the treatment of advanced renal cell carcinoma following one prior antiangiogenic therapy. Lenvatinib was first approved in 2015 for the treatment of locally recurrent or metastatic, progressive, radioactive iodine–refractory differentiated thyroid cancer. Indication approved May 13, 2016.
  • Cabozantinib (Cabometyx), for the treatment of advanced renal cell carcinoma in patients who have received prior antiangiogenic therapy. Indication approved April 25, 2016.
  • Venetoclax (Venclexta), for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy. Indication approved April 11, 2016.
  • Defibrotide sodium (Defitelio), for the treatment of patients with hepatic veno-occlusive disease with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation. Indication aproved March 30, 2016.
  • Crizotinib (Xalkori), for the treatment of patients with metastatic non–small cell lung cancer whose tumors are ROS1-positive. Indication approved March 11, 2016.
  • Everolimus (Afinitor), for the treatment of adults with progressive, well-differentiated nonfunctional, neuroendocrine tumors of gastrointestinal or lung origin with unresectable, locally advanced, or metastatic disease. Indication approved February 26, 2016.
  • Obinutuzumab (Gazyva), for use in combination with bendamustine followed by obinutuzumab monotherapy to treat patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab (Rituxan)-containing regimen. Obinutuzumab was first approved for use in combination with chlorambucil ­(Leukeran) to treat patients with previously untreated CLL. Indication approved February 26, 2016.
  • Palbociclib (Ibrance), combined with fulvestrant (Faslodex) for the treatment of women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression after endocrine therapy. Indication approved February 19, 2016.
  • Eribulin mesylate (Halaven), to treat patients with unresectable or metastatic liposarcoma who have received an anthracycline-containing regimen. Indication approved January 28, 2016.
  • Ofatumumab (Arzerra), for extended treatment of patients in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. Ofatumumab was initially approved in previously untreated CLL patients when fludarabine-based therapy was inappropriate and also in CLL refractory to fludarabine and alemtuzumab (Campath). Indication approved January 19, 2016. ■


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