Assertio's Breakthrough: Rolvedon Same-Day Dosing for Breast Cancer Patients

Assertio Holdings, Inc. (Nasdaq: ASRT) has recently announced the 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 at the San Antonio Breast Cancer Symposium by the American Association of Cancer Research. This groundbreaking study has the potential to revolutionize the treatment options for patients with ESBC, providing them with a more convenient and effective chemotherapy regimen.

The primary endpoint of the clinical trials was the comparison of the duration of severe neutropenia (absolute neutrophil count <0.5×109/L) in Cycle 1. This was measured by evaluating patients' neutrophil counts over time and comparing the duration of severe neutropenia between the Rolvedon and pegfilgrastim groups. The results showed that Rolvedon demonstrated a non-inferior duration of severe neutropenia compared to pegfilgrastim, with a median duration of 1 day for both Rolvedon and pegfilgrastim. This indicates that Rolvedon is as effective as pegfilgrastim in reducing the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.

The Rolvedon same-day dosing clinical study, conducted by Assertio, has shown promising results for patients with early-stage breast cancer. The study found that Rolvedon, an injection of eflapegrastim-xnst, was effective in stimulating the growth of neutrophils, a type of white blood cell crucial for fighting infections, when dosed the same day as chemotherapy. This is a significant advancement as it allows for more convenient and flexible treatment options for patients. The study, presented at the San Antonio Breast Cancer Symposium, demonstrated that Rolvedon reduced the duration of severe neutropenia (low neutrophil count) and febrile neutropenia (fever with low neutrophil count) during the first cycle of chemotherapy. This means that patients may experience fewer side effects and a lower risk of infection, potentially reducing the need for hospitalization. The results of this study could expand the treatment options for patients with early-stage breast cancer, providing them with a more manageable and effective chemotherapy regimen.



In conclusion, the Rolvedon same-day dosing clinical study has shown promising results for patients with early-stage breast cancer. The study found that Rolvedon, an injection of eflapegrastim-xnst, was effective in stimulating the growth of neutrophils when dosed the same day as chemotherapy. This is a significant advancement as it allows for more convenient and flexible treatment options for patients. The study demonstrated that Rolvedon reduced the duration of severe neutropenia and febrile neutropenia during the first cycle of chemotherapy, potentially reducing the need for hospitalization. The results of this study could expand the treatment options for patients with early-stage breast cancer, providing them with a more manageable and effective chemotherapy regimen.