dm+d

Unassigned

New Medicines

Severe neutropenia, resulting from chemotherapy

Information

New molecular entity
Generon
Generon

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
Oct 21Filed in EU via centralised procedure [10].
Mar 21Filed in US [9].
Mar 21expected primary completion of NCT03252431 pivotal trial this month [4]. Generon are expected to seek a licensing partner for commercialisation [5].
Oct 20following successful completion of the PIII trial, Evive intends to submit licensing applications to the EMA and FDA "soon", but expects to commercialise through partner companies [8].
Jul 20Evive Biotech is the new name for Generon Biomed.[6]

Category

Recombinant human Granulocyte Colony Stimulating Factor (rhG-CSF). A dimeric recombinant fusion protein. consists of two granulocyte colony stimulating factor (G-CSF) molecules at the N-terminal of IgG2-Fc fragments
Recombinant human granulocyte-colony stimulating factor (rhG-CSF) is given subcutaneously and stimulates the production of neutrophils in the bone marrow. It may reduce the duration of chemotherapy-induced neutropenia and thereby reduce the incidence of associated sepsis [2].
Severe neutropenia, resulting from chemotherapy
Subcutaneous injection

Trial or other data

Jul 20PIII multi-center, randomized, single dose, double-blind, active-controlled study (NCT03252431) comparing the efficacy and safety of F-627 (dimeric recombinant human granulocyte colony stimulating factor-fc fusion protein) and pegfilgrastim (Neulasta) in the prophylactic treatment of chemotherapy-induced neutropenia in women with breast cancer met its efficacy and safety endpoints [7].
Dec 18PIII (NCT02872103) results announced, subcutaneous administration of F-627 significantly reduced the duration of Grade 4 (severe) neutropenia in chemotherapy cycle 1, the mean treatment difference was 2.8 days (1.1 days vs. 3.9 days in the placebo arm (P