FDA Accepts Resubmitted BLA for Rolontis


The FDA had previously issued a CRL due to manufacturing issues for the therapy, which is seeking an indication for preventing infections after chemotherapy for breast cancer. The agency has set a new PDUFA date of September 9, 2022.

The FDA has accepted the resubmitted biologics license application (BLA) for Rolontis (eflapegrastim). Developed by Spectrum Pharmaceuticals, Rolontis is a long-acting granulocyte colony-stimulating factor (G-CSF) to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Tom Riga

Tom Riga

“The acceptance of the BLA resubmission is an important incremental step forward in the regulatory review process,” Tom Riga, president and chief executive officer of Spectrum, said in a press release. “We are actively working with the agency as they conduct their review and look forward to the potential approval of this novel product.”

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 9, 2022.

The BLA is supported by data from two phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of Rolontis in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, Rolontis demonstrated non-inferiority in duration of severe neutropenia and a similar safety profile to pegfilgrastim.

In August 2021, the FDA issued a complete response letter, citing deficiencies related to manufacturing. Spectrum executives said they have addressed the manufacturing deficiencies. The FDA has indicated that a reinspection of the drug substance manufacturing facility in South Korea will be required.

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