ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials. 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. 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. 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™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. 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." "I am confident that Shanta’s decade-plus experience in clinical development at Spectrum, including her significant involvement in ROLVEDON’s development to date, will enable a seamless transition for our company and all our stakeholders. "We thank Francois for his many contributions to Spectrum and wish him the best in his future endeavors," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.
Lebel will serve as a consultant to Spectrum through March 2023 to facilitate a seamless transition. Chawla was the principal physician on the ROLVEDON™ (eflapegrastim-xnst) injection Phase 3 program and was instrumental in successfully navigating the BLA submission that resulted in the drug’s approval. Shanta Chawla, Vice President, Clinical Development, also effective immediately. The company’s clinical development function will be led by Dr. Lebel, M.D., Executive Vice President and Chief Medical Officer, will step down from his role to pursue other opportunities, effective immediately. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today that Francois J. BOSTON, January 04, 2023-( BUSINESS WIRE)-Spectrum Pharmaceuticals, Inc.
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