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Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Second filgrastim biosimilar approved by FDA

U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi), Pfizer press release

Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim) was approved July 20 by the Food and Drug Administration, according to a statement provided by the agency. Nivestym is the second biosimilar to Neupogen to be approved in the United States.

Nivestym is approved for the same indications as Neupogen and can be prescribed for:

  • Patients with cancer receiving myelosuppressive chemotherapy.
  • Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy.
  • Patients with cancer undergoing bone marrow transplantation.
  • Patients undergoing autologous peripheral blood progenitor cell collection and therapy.
  • Patients with severe chronic neutropenia.

Prescribing information is available here.


U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi), Pfizer press release

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Haplo-HCT shows viability in DLBCL, Dreger P et al. Blood Adv. 2019 Feb 12;3(3):360-9

First-line avelumab/axitinib for RCC benefits wide range of patients, Choueiri TK et al. GUCS 2019, Abstract 544.

Inadequate emergency care a challenge for rural pediatric patients, Walling EB et al. J Oncol Pract. 2019 Jan 31. doi: 10.1200/JOP.18.00115.

QC measures improve with CMS Oncology Care Model, Rocque G et al. J Oncol Pract. 2019. doi: 10. 1200/JOP.18.00390.

Women less likely to receive industry funds, Weng JK et al. JAMA Netw Open. 2019 Jan. 25. doi: 10.1001/jamanetworkopen.2018.7377.

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Rapid genomic results possible, Beat AML trial suggests, Burd A et al. ASH 2018, Abstract 559

Phase 2 results for combo therapy in relapsed AML, Daver N et al. Cancer Discov. 2018 Nov 8. doi: 10.1158/2159-8290.CD-18-0774

Transcription factor networks in AML, Assi SA et al. Nat Genet. 2018 Nov 12. doi: 10.1038/s41588-018-0270-1

Immune system changes play a role in AML relapse, Christopher MJ et al. N Engl J Med. 2018 Oct 31. doi: 10.1056/NEJMoa1808777.