On July 1, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL Trial and the new 133 count commercial NERLYNX SKU (Press release, Puma Biotechnology, JUL 1, 2021, View Source [SID1234584554]). The new 133 count SKU, i.e., a bottle containing a four-week supply of 133 tablets, is aligned with the use of NERLYNX dose escalation and designed to better support patient needs.
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The CONTROL study was a multicenter, open-label, multi-cohort trial evaluating patients with early stage HER2-positive breast cancer treated with NERLYNX 240 mg daily for up to one year who received loperamide prophylaxis with additional anti-diarrheal treatment as needed (PRN) or NERLYNX dose escalation with loperamide as needed. Patients in the dose escalation cohort received NERLYNX 120 mg daily for Week 1, followed by NERLYNX 160 mg daily for Week 2, followed by NERLYNX 240 mg daily for Week 3 and thereafter for the duration of treatment.
Data from this study showed that dose escalation in the extended adjuvant setting, coupled with PRN Loperamide, led to a greater than 60% reduction in the percentage of patients who experienced Grade 3 diarrhea (40% vs. 13%), a 50% reduction in median cumulative days of Grade 3 diarrhea (5 days vs. 2.5 days) and an approximate 80% reduction in discontinuation rates (17% vs. 3%) when compared to ExteNET, where no dose escalation or antidiarrheal prophylaxis was mandated.
Hope S. Rugo, MD, Professor of Medicine at the University of California San Francisco Comprehensive Cancer Center, said, "The inclusion of dose escalation in the prescribing information is a critical road-map for health care providers and patients as they seek to optimize treatment and reduce therapy-related toxicity in the early breast cancer and metastatic settings."
Alan H. Auerbach, Chief Executive Officer and President of Puma, said, "We believe that utilizing dose escalation has the potential to improve the overall tolerability of NERLYNX and increase the average length of therapy, with the end result benefiting more patients battling breast cancer."
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.