dm+d

Unassigned

New Medicines

Rolontis Chemotherapy-induced neutopenia

Information

Rolontis
New molecular entity
Spectrum
Spectrum

Development and Regulatory status

None
Phase III Clinical Trials
Not approved
Nov 21Spectrum held a Type A meeting with the FDA to better understand the issues identified in the Response CRL. At that meeting, the company learned that the deficiencies at the fill finish site have been adequately addressed. Remediation of deficiencies at the drug substance facility are well under way and expected to be completed by the end of the year. The FDA confirmed that the reinspection of the drug substance facility would be in-person [8,9]
Aug 21Complete Response Letter (CRL) received from the FDA for the BLA for eflapegrastim. The CRL cited deficiencies related to manufacturing and indicated that a reinspection will be necessary [8]
Jun 21FDA initiated a pre-approval inspection of the eflapegrastim manufacturing site at the Hanmi Bioplant in South Korea related to BLA approval [8]
Oct 20FDA response to the BLA will be delayed as it has not been able to inspect the manufacturing site due to Covid-19 travel restrictions [7].
Oct 19Spectrum have submitted an updated Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim) [6].
Jun 19Spectrum Pharmaceuticals is currently working on a revised Biologics License Application (BLA) to submit to the FDA [5].
Mar 19In 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due to the FDA´s request for additional manufacturing-related information for Rolontis, the company has voluntarily withdrawn its Biologics License Application (BLA).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 18Biologics License Application (BLA) submitted toFDA for ROLONTIS® (eflapegrastim)[3].
Feb 18Spectrum plans to file in EU in 2019 [2].
Nov 17Spectrum 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 18Spectrum 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 17Pivotal 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 15PIII 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].