Eflapegrastim

Unassigned

New Medicines

Rolontis · Chemotherapy-induced neutopenia

Information

Rolontis
New molecular entity
Spectrum
Spectrum

Development and Regulatory status

None
Phase III Clinical Trials
Pre-registration (Filed)
Oct 19 · Spectrum have submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim) [6].
Jun 19 · Spectrum Pharmaceuticals is currently working on a revised Biologics License Application (BLA) to submit to the FDA [5].
Mar 19 · In the US, Spectrum Pharmaceuticals announced that due to the FDA´s request for additional manufacturing-related information for Rolontis, the company has voluntarily withdrawn its Biologics License Application (BLA). Spectrum plans to resubmit a revised BLA as soon as possible [4].
Dec 18 · Biologics License Application (BLA) submitted toFDA for ROLONTIS® (eflapegrastim)[3].
Feb 18 · Spectrum plans to file in EU in 2019 [2].
Nov 17 · Spectrum Pharmaceuticals plans to submit BLA to US FDA in Q4 2018 [2].

Category

Long‐acting granulocyte colony‐stimulating factor (G‐CSF) analogue, injected every 3 weeks.
Neutropenia is associated with cancer chemotherapy. Moderate neutropenia is defined as neutrophil count of 0.5-1.0 x 109/L, severe neutropenia is a count of <0.5 x 109/L.
Chemotherapy-induced neutopenia
Subcutaneous injection

Trial or other data

Feb 18 · Spectrum Pharmaceuticals announces treatment with eflapegrastim met its primary endpoint of non-inferiority in duration of severe neutropenia between eflapegrastim and pegfilgrastim in the PIII ADVANCE trial (NCT02643420) [2].
May 17 · Pivotal PIII RECOVER trial to assess the safety and efficacy of eflapegrastim for the treatment of chemotherapy-induced neutropenia in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide starts (SPI-GCF-302; NCT02953340). 218 patients will be recruited in the US. Primary endpoint is the duration of severe neutropenia (Absolute Neutrophil Counts [ANC] <0.5×109/L) in cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 days cycle. Secondary endpoints include the incidence of neutropenic complications, incidence of febrile neutropenia, relative dose intensity and safety [1].
Dec 15 · PIII registrational ADVANCE trial for the treatment of chemotherapy-induced neutropenia in patients with newly diagnosed, early-stage breast cancer starts (NCT02643420). 406 patients will be randomised to SC eflapegrastim or pegfilgrastim in the US and Canada. The study is powered at over 90% for non-inferiority and at 80% for superiority to pegfilgrastim [1].