Spectrum Pharmaceuticals Announces Submission of Biologics License Application to the FDA for ROLONTIS® (eflapegrastim) as a Treatment for Chemotherapy-Induced Neutropenia
- Submission based on results from two large, positive pivotal trials
- Both pivotal trials successfully met their primary endpoint and all secondary endpoints
- ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) that utilizes a proprietary platform technology to maximize the pharmacological activity of G-CSF
“ROLONTIS is an important and significant future growth driver for our
company,” said Joe Turgeon, President and CEO of
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 cytoxic chemotherapy. The study ADVANCE was conducted under a special protocol assessment (SPA) with the Agency. 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 studies.
About
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in hematology and oncology. Spectrum currently markets seven hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the company. Spectrum's strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
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Source:
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com