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BOSTON--(BUSINESS WIRE)--Dec 6, 2022--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology announced today that ROLVEDON (eflapegrastim-xnst) has been added to the latest National Comprehensive Cancer Network® Supportive Care Guidelines (NCCN Guidelines) in oncology for Hematopoietic Growth Factors. The NCCN Guidelines provide recommendations for the appropriate use of growth factors in the clinical management of febrile neutropenia (FN) and now include ROLVEDON as a treatment option under Management of Neutropenia: G-CSFs for Prophylaxis of Febrile Neutropenia and Maintenance of Scheduled Dose Delivery.
“We are pleased with the rapid inclusion of ROLVEDON in the NCCN guidelines as an appropriate option for cancer patients who are at risk for febrile neutropenia.” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “The NCCN guidelines are a standard resource for determining the best course of treatment and supportive care for people living with cancer. The inclusion in the NCCN guidelines further reinforces the clinical profile of ROLVEDON and is an important milestone for the program.”
The NCCN is a not-for-profit alliance of 32 leading cancer centers devoted to patient care, research, and education. The NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine. For more information visit: https://www.nccn.org/guidelines/guidelines-process/about-nccn-clinical-practice-guidelines.
About ROLVEDON™
ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.
Please see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com.
Indications and Usage
ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Limitations of Use
ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Important Safety Information
Contraindications
Warnings and Precautions
Splenic Rupture
Acute Respiratory Distress Syndrome (ARDS)
Serious Allergic Reactions
Sickle Cell Crisis in Patients with Sickle Cell Disorders
Glomerulonephritis
Leukocytosis
Thrombocytopenia
Capillary Leak Syndrome
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
Aortitis
Nuclear Imaging
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. 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 pipeline with novel assets that serve areas of unmet need. For additional information on Spectrum please visit www.sppirx.com.
Notice Regarding Forward-looking Statements
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum’s business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE™ and ROLVEDON™ are the Spectrum Pharmaceuticals’ logos and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2022 Spectrum Pharmaceuticals, Inc. All Rights Reserved
View source version on businesswire.com:https://www.businesswire.com/news/home/20221206005351/en/
CONTACT: Tom Riga
Chief Executive Officer
949.788.6700
InvestorRelations@sppirx.comLisa Wilson
In-Site Communications, Inc.
212.452.2793
lwilson@insitecony.com
KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: ONCOLOGY HEALTH RESEARCH PHARMACEUTICAL SCIENCE BIOTECHNOLOGY
SOURCE: Spectrum Pharmaceuticals, Inc.
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PUB: 12/06/2022 07:00 AM/DISC: 12/06/2022 07:02 AM
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