trending Market Intelligence /marketintelligence/en/news-insights/trending/txuKKSMF2CJuj5jXqrEGqw2 content esgSubNav
Log in to other products


Looking for more?

Contact Us
In This List

Spectrum Pharmaceuticals seeks US FDA approval for neutropenia therapy


COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021


Climate Credit Analytics: Linking climate scenarios to financial impacts


Global M&A Infographic Q1 2021


Q1 2021 Global Capital Markets Activity: SPAC IPOs, Issuance in Consumer Discretionary Sector Surge

Spectrum Pharmaceuticals seeks US FDA approval for neutropenia therapy

Spectrum Pharmaceuticals Inc. is seeking U.S. approval for its drug to treat chemotherapy-induced neutropenia.

The Henderson, Nev.-based biotechnology company said it submitted a biologics license application to the U.S. Food and Drug Administration for Rolontis, or eflapegrastim, to treat the condition characterized by an abnormally low level of the white blood cells that are depleted during chemotherapy and which can lead to infection and sepsis.

Two phase 3 studies dubbed Advance and Recover compared Rolontis with Amgen Inc.'s Neulasta, or pegfilgrastim, in over 643 early-stage breast cancer patients and found no meaningful differences between the two therapies, Spectrum Pharmaceuticals said. The Advance study is being conducted under a special protocol assessment with the FDA, which allows for submission of results from incomplete trials for approval.