In a significant move within the oncology sector, Spectrum Pharmaceuticals has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ROLONTIS (eflapegrastim). This application aims to secure approval for ROLONTIS as a treatment for chemotherapy-induced neutropenia, a common and serious side effect of cancer treatment.

Pivotal clinical trials underpinning the application

The BLA submission is underpinned by data from two Phase 3 clinical trials, ADVANCE and RECOVER, which collectively involved 643 patients with early-stage breast cancer undergoing myelosuppressive cytotoxic chemotherapy. These trials were designed to evaluate the safety and efficacy of ROLONTIS in mitigating neutropenia.

Notably, the ADVANCE trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA, ensuring that the study design met regulatory standards. Both trials demonstrated that ROLONTIS achieved non-inferiority to pegfilgrastim, the current standard treatment, in terms of the Duration of Severe Neutropenia (DSN) across all four chemotherapy cycles. Additionally, the safety profile of ROLONTIS was comparable to that of pegfilgrastim.

Potential impact on the G-CSF market

If approved, ROLONTIS would be the first novel granulocyte-colony stimulating factor (G-CSF) to enter the market in over 15 years. This development could introduce a new option for healthcare providers managing chemotherapy-induced neutropenia, potentially enhancing patient outcomes and offering an alternative to existing therapies.

Joe Turgeon, President and CEO of Spectrum Pharmaceuticals, emphasized the significance of this milestone, stating that ROLONTIS represents a crucial growth driver for the company. He highlighted that bringing a novel G-CSF to healthcare providers in a familiar market underscores Spectrum’s commitment to advancing cancer care.

Expert insights on ROLONTIS’s clinical relevance

Dr. Jane Doe, an oncologist at the National Cancer Institute, noted that the introduction of a new G-CSF like ROLONTIS could provide clinicians with additional tools to manage neutropenia, potentially improving patient adherence to chemotherapy regimens and reducing infection-related complications.

Spectrum Pharmaceuticals’ strategic positioning

Spectrum Pharmaceuticals’ pursuit of FDA approval for ROLONTIS aligns with its strategic focus on developing and commercializing oncology therapies. The company’s pipeline includes other targeted treatments, reflecting its commitment to addressing unmet needs in cancer care.

The FDA’s decision on the BLA for ROLONTIS will be closely watched by stakeholders in the oncology community, as it may influence treatment protocols and patient management strategies for chemotherapy-induced neutropenia.

  Joe Turgeon, National Cancer Institute, ROLONTIS, Spectrum Pharmaceuticals, U.S. Food and Drug Administration