HENDERSON, Nevada – (BUSINESS WIRE) – August 6, 2021–
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company specializing in innovative and targeted cancer therapies, today announced that it has received a Full Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the application for a biological product license (BLA) from the company for ROLONTIS® (éflapégrastim). CRL cited manufacturing deficiencies and indicated that re-inspection will be required. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.
“We are disappointed with this result and look forward to fully understanding the program remediation timelines,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. “We continue to believe in ROLONTIS and plan to diligently complete the regulatory process to bring ROLONTIS to market. “
ROLONTIS is a novel long-acting granulocyte colony stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anticancer drugs. The ROLONTIS BLA 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 patients with early-stage breast cancer for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the predefined non-inferiority (NI) hypothesis of the duration of severe neutropenia (DSN) and a safety profile similar to that of pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN over the 4 cycles (all NI p
AboutSpectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on the acquisition, development and commercialization of new and targeted oncology therapies. Spectrum has a strong track record of successfully executing the biopharmaceutical business model, from licensing and acquisition of differentiated drugs, to clinical development of new assets, to successful regulatory approvals and commercialization. in a competitive healthcare market. Spectrum has an advanced pipeline with new assets that meet unmet needs. This pipeline has the potential to transform the business in the near future. For more information on Spectrum Pharmaceuticals, please visit www.sppirx.com.
Notice Regarding Forward-Looking Statements
Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to various matters, including, without limitation, statements relating to Spectrum’s business and its future, including the timing and outcome of the FDA re-inspection of the Hanmi bioplante in South Korea. , the timing and outcome of the company’s planned meeting with the FDA, including the company’s ability to remedy the cited deficiencies and the associated timeline, the overall likelihood of success, and the timeline for the ABL of the ‘business for ROLONTIS and the company’s ability to bring ROLONTIS to market, the future potential of Spectrum’s existing drug pipeline products, including ROLONTIS, and other statements that are not purely statements of historical fact. These forward-looking statements are made based on the current beliefs, understandings, expectations and assumptions of Spectrum’s management and are subject to significant risks and uncertainties that could cause actual results to differ materially from what can be expressed or understood. – understood in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the possibility that the different methodologies, assumptions and applications used by the Company to assess particular parameters of safety or efficacy may produce statistical results. different, and although the company believes the data collected from clinical trials of its product candidates, including poziotinib, is positive, that data may not be sufficient to warrant FDA approval; the possibility that the success of the first clinical trials, especially if they are based on a small sample of patients, will not lead to the success of the subsequent clinical trials, and other unforeseen events during the clinical trials which could lead to delays or other undesirable consequences; other uncertainties inherent in the development of new products; the possibility that Spectrum’s new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective; the possibility that Spectrum’s new and existing drug candidates, if approved, may not be more effective, safer or more cost-effective than competing drugs; and other risks which are more fully described in the Company’s reports filed with the Securities and Exchange Commission (the “SEC”). The company does not intend to update these forward-looking statements and expressly disclaims any obligation to update the information contained in this press release, except as required by law. For more information about the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Spectrum’s business in general, see the risk information in the annual report on Spectrum’s Form 10-K for the fiscal year ended December 31, 2020, and in subsequent reports on Forms 10-K, 10-Q and 8-K and other documents filed with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC. ® and ROLONTIS ®are registered trademarks of Spectrum Pharmaceuticals, Inc. and its subsidiary. REDEFINING CANCER CARE ™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
© 2021 Spectrum Pharmaceuticals, Inc. All rights reserved
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KEYWORD: UNITED STATES NORTH AMERICA NEVADA
INDUSTRY KEYWORD: FDA BIOTECHNOLOGY PHARMACEUTICAL HEALTH ONCOLOGY
SOURCE: Spectrum Pharmaceuticals
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PUB: 06.08.2021 07:30 / DISC: 06.08.2021 07:32
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