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.
“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.