Assertio Therapeutics, INC (ASRT)

[dcaf7]

From VA Formulary Advisor.
Projected Place in Therapy/Conclusions
• In 2 phase III clinical trials in patients with early breast cancer receiving myelosuppressive chemotherapy for 4
cycles in the adjuvant setting, eflapegrastim was non-inferior to pegfilgrastim in reducing the duration of severe
neutropenia during cycle 1 (primary endpoint) and during cycles 2-4 (secondary endpoint). Pooled rates of febrile
neutropenia for this chemotherapy combination without G-CSF prophylaxis are 29.1%.
• Safety during the clinical trial (adverse reactions in ≥20%) was similar between eflapegrastim and pegfilgrastim
despite the fact that eflapegrastim provides a lower dose of G-CSF compared to pegfilgrastim. The package
labeling for both products contains the same contraindication and Warnings and Precautions.
• There is no clear place in therapy for eflapegrastim instead of pegfilgrastim.
https://www.va.gov/formularyadvisor/DOC/466