HENDERSON, NV, USA I March 15, 2019 I Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) announced today that due to the U.S. Food and Drug Administration’s (FDA) request for additional manufacturing-related information for ROLONTIS, the company has voluntarily withdrawn its Biologics License Application (BLA).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.
The FDA did not cite concerns related to the pre-clinical and clinical modules of the BLA or the need for additional clinical studies. Spectrum’s decision to withdraw the BLA was the result of the company needing more time to provide certain additional manufacturing-related information, which was required before March 29, 2019, the day that the FDA’s initial 60-day review period ends.
“We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We remain confident in the ROLONTIS program and look forward to a successful resubmission and its ultimate approval.”
ROLONTIS is being evaluated as a novel therapy for the management of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products, with a primary focus in hematology and oncology. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future.
SOURCE: Spectrum Pharmaceuticals
Post Views: 78
HENDERSON, NV, USA I March 15, 2019 I Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) announced today that due to the U.S. Food and Drug Administration’s (FDA) request for additional manufacturing-related information for ROLONTIS, the company has voluntarily withdrawn its Biologics License Application (BLA).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.
The FDA did not cite concerns related to the pre-clinical and clinical modules of the BLA or the need for additional clinical studies. Spectrum’s decision to withdraw the BLA was the result of the company needing more time to provide certain additional manufacturing-related information, which was required before March 29, 2019, the day that the FDA’s initial 60-day review period ends.
“We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We remain confident in the ROLONTIS program and look forward to a successful resubmission and its ultimate approval.”
ROLONTIS is being evaluated as a novel therapy for the management of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted drug products, with a primary focus in hematology and oncology. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future.
SOURCE: Spectrum Pharmaceuticals
Post Views: 78
