{"id":458343,"date":"2021-03-16T07:03:06","date_gmt":"2021-03-16T11:03:06","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=458343"},"modified":"2021-03-16T07:03:06","modified_gmt":"2021-03-16T11:03:06","slug":"spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\/","title":{"rendered":"Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection"},"content":{"rendered":"

<\/p>\n

Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection<\/b><\/p>\n

HENDERSON, Nev.–(BUSINESS WIRE<\/a>)–
\nSpectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS\u00ae (eflapegrastim) manufacturing site in May 2021. In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic.\n<\/p>\n

\n\u201cI am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May,\u201d said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. \u201cWe believe the pre-approval inspection marks the final step in the ROLONTIS review process.\u201d\n<\/p>\n

About ROLONTIS <\/b><\/p>\n

\nROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. 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 chemotherapy. 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 trials.\n<\/p>\n

About<\/b>Spectrum Pharmaceuticals, Inc. <\/b><\/p>\n

\nSpectrum Pharmaceuticals 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 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. For additional information on Spectrum Pharmaceuticals, please visit www.sppirx.com<\/a>.\n<\/p>\n

Notice Regarding Forward-Looking Statements<\/i><\/b><\/p>\n

Certain statements in this press release may constitute \u201cforward-looking statements\u201d within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum\u2019s business and its future, including the timing and outcome of the FDA\u2019s inspection of the Hanmi Bioplant in South Korea, the FDA\u2019s ability to complete the inspection, the overall likelihood of success and timing of the company\u2019s BLA for ROLONTIS, the future potential of Spectrum\u2019s existing drug pipeline, including ROLONTIS, and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, understandings, expectations, and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied 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 the company utilizes to assess particular safety or efficacy parameters may yield different statistical results, and even if the company believes the data collected from the clinical trials of its product candidates, including poziotinib, are positive, these data may not be sufficient to support approval by the FDA; the possibility that success in early clinical trials, especially if based on a small patient sample, might not result in success in later clinical trials, and other unforeseen events during clinical trials which could cause delays or other adverse consequences; other uncertainties inherent in new product development; the possibility that Spectrum\u2019s new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective; the possibility that Spectrum\u2019s new and existing drug candidates, if approved, may not be more effective, safer, or more cost efficient than competing drugs; and other risks that are described in further detail in the company’s reports filed with the Securities and Exchange Commission (the \u201cSEC\u201d). 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. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Spectrum in general, see the risk disclosures in the Annual Report on Form 10-K of Spectrum for the year ended December 31, 2019, and in subsequent reports on Forms 10-K, 10-Q and 8-K and other filings made with the SEC by Spectrum. <\/i><\/p>\n

SPECTRUM PHARMACEUTICALS, INC.\u00ae<\/sup> and ROLONTIS\u00ae<\/sup><\/i>are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliate. REDEFINING CANCER CARE\u2122 and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.<\/i><\/p>\n

\u00a9 2021 Spectrum Pharmaceuticals, Inc. All Rights Reserved<\/i><\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210316005343\/en\/<\/a><\/span><\/p>\n

\nRobert Uhl
\n
Managing Director, Westwicke ICR
\n
858.356.5932
\n
robert.uhl@westwicke.com
\n<\/a><\/p>\n

Kurt Gustafson
\n
Chief Financial Officer
\n
949.788.6700
\n
InvestorRelations@sppirx.com<\/a><\/p>\n

KEYWORDS:<\/b> Nevada South Korea United States North America Asia Pacific<\/p>\n

INDUSTRY KEYWORDS:<\/b> Biotechnology FDA Health Pharmaceutical Oncology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS\u00ae (eflapegrastim) manufacturing site in May 2021. In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic. \u201cI am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May,\u201d … <\/p>\n

Continue reading “Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-458343","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nSpectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the pre-approval inspection at the ROLONTIS\u00ae (eflapegrastim) manufacturing site in May 2021. In October 2020, the company received notification from the agency that it would defer its decision on the BLA because an inspection of the Hanmi Bioplant in South Korea could not be conducted during the review cycle due to restrictions on travel related to the COVID-19 pandemic. \u201cI am thrilled that the FDA informed us that they will be conducting a pre-approval inspection of the ROLONTIS manufacturing facility in May,\u201d … Continue reading "Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-16T11:03:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210316005343r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection\",\"datePublished\":\"2021-03-16T11:03:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\\\/\"},\"wordCount\":902,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210316005343r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/spectrum-pharmaceuticals-provides-update-on-rolontis-eflapegrastim-pre-approval-inspection\\\/\",\"name\":\"Spectrum Pharmaceuticals Provides Update on ROLONTIS\u00ae (eflapegrastim) Pre-Approval Inspection - 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