The Biologics License Application (BLA) for Ryzneuta™ (efbemalenograstim alfa; Evive Biotech) has been submitted to the Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neutropenia (CIN).
Ryzneuta, also known as F-627, is an investigational, recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal. It utilizes the Company’s proprietary DiKine™ fusion protein platform to stimulate survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils.
The BLA submission is supported by data from two phase 3 trials (ClinicalTrials.gov: NCT03252431 and NCT02872103) that evaluated the efficacy and safety of Ryzneuta in adult women with Stage I-III and Stage II-IV breast cancer, respectively, receiving chemotherapy treatment. In the NCT03252431 study, patients were randomly assigned to receive either Ryzneuta or Neulasta subcutaneously on day 2 of each 4 chemotherapy cycles. In the NCT02872103 study, patients were randomly assigned to receive either Ryzneuta or placebo.
The primary endpoint for both studies was the duration in days of grade 4 neutropenia in chemotherapy cycle 1, defined as the number of days with an absolute neutrophil count less than 0.5×109/L.
Results for the placebo-controlled study, showed that patients treated with Ryzneuta had a mean duration of 1.3 days of grade 4 neutropenia compared with 3.9 days for placebo (P <.0001). Full results from the Neulasta controlled study have not been released yet, however the Company state that the primary endpoint was met.
“Neutropenia is a common and potentially life-threatening complication for cancer patients,” said Dr. William Dailey, Evive Biotech’s Chief Medical Officer. “Submission of our BLA is an important step that brings us closer to providing a strong first-line treatment and an alternative to patients who are contraindicated or refractory to current treatment options.”
1. Evive Biotech submits Biologics License Application to US FDA for Ryzneuta(™). [press release]. Singapore: Evive Biotech; March 31, 2021.
2. Evive successfully concludes first phase III clinical trial of F-627 for chemotherapy-induced neutropenia and met primary endpoints. [press release]. Shanghai, China: Evive Biotech; January 25, 2018.