{"id":52514,"date":"2023-01-04T13:02:10","date_gmt":"2023-01-04T12:02:10","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/spectrum-pharmaceuticals-announces-management-changes\/"},"modified":"2023-01-04T13:02:10","modified_gmt":"2023-01-04T12:02:10","slug":"spectrum-pharmaceuticals-announces-management-changes","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/spectrum-pharmaceuticals-announces-management-changes\/","title":{"rendered":"Spectrum Pharmaceuticals Announces Management Changes"},"content":{"rendered":"<div>\n<p>BOSTON&#8211;(BUSINESS WIRE)&#8211;Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that Francois J. Lebel, M.D., Executive Vice President and Chief Medical Officer, will step down from his role to pursue other opportunities, effective immediately. The company\u2019s clinical development function will be led by Dr. Shanta Chawla, Vice President, Clinical Development, also effective immediately. Dr. Chawla was the principal physician on the ROLVEDON\u2122 (eflapegrastim-xnst) injection Phase 3 program and was instrumental in successfully navigating the BLA submission that resulted in the drug\u2019s approval. Dr. Lebel will serve as a consultant to Spectrum through March 2023 to facilitate a seamless transition.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230104005148\/en\/833213\/4\/NEW_Logo_Spectrum.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230104005148\/en\/833213\/21\/NEW_Logo_Spectrum.jpg\"><\/a><\/p>\n<p>\n\u201cWe thank Francois for his many contributions to Spectrum and wish him the best in his future endeavors,\u201d said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. \u201cI am confident that Shanta\u2019s decade-plus experience in clinical development at Spectrum, including her significant involvement in ROLVEDON\u2019s development to date, will enable a seamless transition for our company and all our stakeholders. We remain focused on furthering the successful launch of ROLVEDON, the first new novel LA-GCSF in more than 20 years, and are excited about its ability to compete in a $2 billion market while improving the lives of patients.\u201d\n<\/p>\n<p>\n<b>About ROLVEDON\u2122<\/b>\n<\/p>\n<p>\nROLVEDON\u2122 (eflapegrastim-xnst)<b> <\/b>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&lt;0.0001) in both trials.\n<\/p>\n<p>\nPlease see the Important Safety Information below and the full prescribing information for ROLVEDON at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.rolvedon.com%2Fpdf%2Frolvedon-prescribing-information.pdf&amp;esheet=53159851&amp;newsitemid=20230104005148&amp;lan=en-US&amp;anchor=www.rolvedon.com&amp;index=1&amp;md5=72d57e76fbb1f01ec6e4f58faf6bd1ee\" rel=\"nofollow noopener\" shape=\"rect\">www.rolvedon.com<\/a>.\n<\/p>\n<p>\n<b>Indications and Usage<\/b>\n<\/p>\n<p>\nROLVEDON 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.\n<\/p>\n<p>\n<span class=\"bwuline\">Limitations of Use<\/span>\n<\/p>\n<p>\nROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.\n<\/p>\n<p>\n<b>Important Safety Information<\/b>\n<\/p>\n<p>\n<b>Contraindications<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nROLVEDON is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim products. Reactions may include anaphylaxis.\n<\/li>\n<\/ul>\n<p>\n<b>Warnings and Precautions<\/b>\n<\/p>\n<p>\n<b>Splenic Rupture<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSplenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.\n<\/li>\n<\/ul>\n<p>\n<b>Acute Respiratory Distress Syndrome (ARDS)<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nARDS can occur in patients receiving rhG-CSF products. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS.\n<\/li>\n<\/ul>\n<p>\n<b>Serious Allergic Reactions<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSerious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience serious allergic reactions.\n<\/li>\n<\/ul>\n<p>\n<b>Sickle Cell Crisis in Patients with Sickle Cell Disorders<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSevere and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell crisis occurs.\n<\/li>\n<\/ul>\n<p>\n<b>Glomerulonephritis<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nGlomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation. Evaluate and consider dose reduction or interruption of ROLVEDON if causality is likely.\n<\/li>\n<\/ul>\n<p>\n<b>Leukocytosis<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nWhite blood cell (WBC) counts of 100 x 10<sup>9<\/sup>\/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of 100 x 10<sup>9<\/sup>\/L or greater occurs.\n<\/li>\n<\/ul>\n<p>\n<b>Thrombocytopenia<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.\n<\/li>\n<\/ul>\n<p>\n<b>Capillary Leak Syndrome<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nCapillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.\n<\/li>\n<\/ul>\n<p>\n<b>Potential for Tumor Growth Stimulatory Effects on Malignant Cells<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe granulocyte colony-stimulating factor (G-CSF) receptor through which ROLVEDON acts has been found on tumor cell lines. The possibility that ROLVEDON acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which ROLVEDON is not approved, cannot be excluded.\n<\/li>\n<\/ul>\n<p>\n<b>Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nMDS and AML have been associated with the use of rhG-CSF products in conjunction with chemotherapy and\/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS\/AML in these settings.\n<\/li>\n<\/ul>\n<p>\n<b>Aortitis<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nAortitis has been reported in patients receiving rhG-CSF products. It may occur as early as the first week after start of therapy. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) without known etiology. Discontinue ROLVEDON if aortitis is suspected.\n<\/li>\n<\/ul>\n<p>\n<b>Nuclear Imaging<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIncreased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.\n<\/li>\n<\/ul>\n<p>\n<b>Adverse Reactions<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nThe most common adverse reactions (\u226520%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.\n<\/li>\n<li>\nPermanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.\n<\/li>\n<\/ul>\n<p>\n<b>To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at 1\u2011800\u2011FDA\u20111088 or <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&amp;esheet=53159851&amp;newsitemid=20230104005148&amp;lan=en-US&amp;anchor=www.fda.gov%2Fmedwatch&amp;index=2&amp;md5=80dc741a00a4bf6d493ab36f019d55b6\" rel=\"nofollow noopener\" shape=\"rect\">www.fda.gov\/medwatch<\/a><\/b>\n<\/p>\n<p>\n<b>About Spectrum Pharmaceuticals, Inc.<\/b>\n<\/p>\n<p>\nSpectrum 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. For additional information on Spectrum please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sppirx.com%2F&amp;esheet=53159851&amp;newsitemid=20230104005148&amp;lan=en-US&amp;anchor=www.sppirx.com&amp;index=3&amp;md5=2a9ba1ae86182ede3eb83bd564a7136e\" rel=\"nofollow noopener\" shape=\"rect\">www.sppirx.com<\/a>.\n<\/p>\n<p>\n<b><i>Notice Regarding Forward-looking Statements<\/i><\/b>\n<\/p>\n<p>\n<i>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&#8217;s current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum\u2019s business and its future, including the success of the company\u2019s clinical development efforts and commercial launch of ROLVEDON, Spectrum&#8217;s ability to identify, acquire, develop and commercialize novel and targeted oncology therapies, 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\u2019s existing and new drug candidates may not prove safe or effective, or may not be more effective, safer or more cost efficient than competing drugs, the possibility that our applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, 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&#8217;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.<\/i>\n<\/p>\n<p>\n<i>SPECTRUM PHARMACEUTICALS, INC.\u00ae is a registered trademark of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE\u2122 and ROLVEDON\u2122 are the Spectrum Pharmaceuticals\u2019 logos and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.<\/i>\n<\/p>\n<p>\n<i>\u00a9 202<\/i><i>3 Spectrum Pharmaceuticals, Inc. All Rights Reserved<\/i>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nTom Riga<br \/>\n<br \/>Chief Executive Officer<br \/>\n<br \/>949.788.6700<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;o&#x3a;I&#x6e;v&#x65;s&#x74;&#111;&#x72;&#82;&#x65;&#108;&#x61;&#116;&#x69;&#111;&#x6e;&#115;&#x40;&#115;p&#x70;i&#x72;x&#x2e;c&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">&#73;&#x6e;v&#x65;&#x73;&#116;&#x6f;r&#x52;&#x65;&#108;&#x61;t&#x69;&#x6f;&#110;&#x73;&#64;&#x73;&#x70;&#112;&#x69;r&#x78;&#x2e;&#99;&#x6f;m<\/a>\n<\/p>\n<p>\nLisa Wilson<br \/>\n<br \/>In-Site Communications, Inc.<br \/>\n<br \/>212.452.2793<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#x69;l&#116;&#x6f;:&#108;&#x77;i&#108;&#x73;o&#110;&#x40;&#x69;&#110;&#x73;&#x69;t&#101;&#x63;o&#110;&#x79;&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">lwilso&#110;&#64;&#105;&#110;&#115;&#105;&#116;&#x65;&#x63;&#x6f;&#x6e;&#x79;&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>BOSTON&#8211;(BUSINESS WIRE)&#8211;Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that Francois J. Lebel, M.D., Executive Vice President and Chief Medical Officer, will step down from his role to pursue other opportunities, effective immediately. The company\u2019s clinical development function will be led by Dr. Shanta Chawla, Vice &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/spectrum-pharmaceuticals-announces-management-changes\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-52514","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Spectrum Pharmaceuticals Announces Management Changes - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/spectrum-pharmaceuticals-announces-management-changes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Spectrum Pharmaceuticals Announces Management Changes - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BOSTON&#8211;(BUSINESS WIRE)&#8211;Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that Francois J. Lebel, M.D., Executive Vice President and Chief Medical Officer, will step down from his role to pursue other opportunities, effective immediately. The company\u2019s clinical development function will be led by Dr. Shanta Chawla, Vice ... 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(NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that Francois J. Lebel, M.D., Executive Vice President and Chief Medical Officer, will step down from his role to pursue other opportunities, effective immediately. The company\u2019s clinical development function will be led by Dr. Shanta Chawla, Vice ... 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