Friday, August 13, 2021

Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim)

Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for Rolontis® (eflapegrastim). The CRL cited deficiencies related to manufacturing and indicated that a reinspection will be necessary. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.

“We are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We continue to believe in Rolontis and plan to diligently complete the regulatory process to bring Rolontis to market.”

About Rolontis

Rolontis is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for Rolontis is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of Rolontis in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, Rolontis demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. Rolontis also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

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