{"id":48193,"date":"2022-09-09T23:01:45","date_gmt":"2022-09-09T21:01:45","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/spectrum-pharmaceuticals-receives-fda-approval-for-rolvedon-eflapegrastim-xnst-injection\/"},"modified":"2022-09-09T23:01:45","modified_gmt":"2022-09-09T21:01:45","slug":"spectrum-pharmaceuticals-receives-fda-approval-for-rolvedon-eflapegrastim-xnst-injection","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/spectrum-pharmaceuticals-receives-fda-approval-for-rolvedon-eflapegrastim-xnst-injection\/","title":{"rendered":"Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON\u2122 (eflapegrastim-xnst) Injection"},"content":{"rendered":"
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\nFirst novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years<\/i>\n<\/p>\n

\nROLVEDON<\/i>\u2122<\/i> developed using proprietary LAPSCOVERY<\/i>\u2122 <\/i>technology with a differentiated molecular structure and proven safety and efficacy profile<\/i>\n<\/p>\n

\nCommercial team ready to launch with product available in the fourth quarter<\/i>\n<\/p>\n

BOSTON–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved ROLVEDON\u2122 (eflapegrastim-xnst) injection 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

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\n\u201cROLVEDON\u2019s approval marks Spectrum\u2019s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,\u201d said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. \u201cThis approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical. On behalf of Spectrum, I would like to thank all of the patients, families, health care providers, and our own team members for bringing this goal to fruition.\u201d\n<\/p>\n

\n\u201cOur commercial team is in place and ready to engage key stakeholders immediately,\u201d said Erin Miller, Senior Vice President, Sales & Marketing of Spectrum Pharmaceuticals. \u201cEquipped with extensive long-acting growth factor market experience, customer connectivity and learnings from in-depth market research insights, we are ready to optimize the launch trajectory. We expect to have product available in the fourth quarter of 2022 following the fulfillment of customary, pre-launch regulatory requirements.\u201d\n<\/p>\n

\nAbout ROLVEDON\u2122<\/b>\n<\/p>\n

\nROLVEDON\u2122 (eflapegrastim-xnst) <\/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<0.0001) in both trials.\n<\/p>\n

\nPlease see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com<\/a>.\n<\/p>\n

\nIndications and Usage<\/b>\n<\/p>\n

\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

\nLimitations of Use<\/span>\n<\/p>\n

\nROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.\n<\/p>\n

\nImportant Safety Information<\/b>\n<\/p>\n

\nContraindications<\/b>\n<\/p>\n