Assertio Announces Results of Rolvedon Injection Same-Day Dosing Clinical Study
Assertio Holdings, Inc. recently announced results of a clinical trial investigating the utility of Rolvedon (eflapegrastim-xnst) injection when dosed the same day of chemotherapy for patients with early stage breast cancer (ESBC). The results were presented as part of the San Antonio Breast Cancer Symposium by the American Association of Cancer Research and the University of Texas Health Science Center at San Antonio.
In this open-label, single-arm study (NCT04187898), conducted across 13 sites in the US, individuals received Rolvedon 30 minutes post chemotherapy for ESBC. Rolvedon demonstrated 1.8 days to neutrophil count recovery and a febrile neutropenia rate of 2%. Zero patients required the need for hospitalization and/or intervention for febrile neutropenia. No new safety signals were identified.
“We are pleased with the expected, positive results from the Rolvedon same day dosing trial and the evidence supporting our belief that Rolvedon can make a meaningful difference for patients undergoing chemotherapy. This milestone further underscores our commitment to improving the lives of patients undergoing cancer treatment by providing convenient and effective treatment options,” said Brendan O’Grady, CEO of Assertio Therapeutics.
“The excellent safety and efficacy profile of Rolvedon in this trial is very encouraging, providing clinical data indicating that same day dosing outcomes are safe and effective for this unique molecule,” said Dr. Howard Franklin, SVP of Medical of Assertio Therapeutics. “Our goal is to enhance patient outcomes and quality of life (QoL), and these results support the potential of Rolvedon to do just that.”
Details of the study and poster presentation can be found at the SABCS website, https://sabcs.org/.
Assertio is a commercial pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients. We have built our commercial portfolio through acquisition or licensing of approved products. Our commercial capabilities include marketing through both a sales force and a non-personal promotion model, market access through payor contracting, and trade and distribution. For more information, visit www.assertiotx.com.
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