Flatiron Health Real-World Data Support FDA Approval of New Dosing Regimen for ERBITUX® (cetuximab)
Dec 19, 2023
Flatiron Health real-world data (RWD) supported the U.S. Food and Drug Administration (FDA)’s recent approval of a new dosing regimen for ERBITUX® (Eli Lilly and Company’s cetuximab) that can have a direct positive impact on the lives of patients with metastatic colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN). The FDA approved a supplemental biologics license application (sBLA) for ERBITUX which provides a new, biweekly dosing regimen for the medicine’s indicated use in patients with K-Ras wild-type, EGFR-expressing metastatic CRC or SCCHN, when used as a single agent or in combination with chemotherapy. This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.
Radiation Oncologists Met With Congressional Leaders to Reverse CMS Cuts and Provide Equal Access to Care
Radiation oncologists met with Congress to urge leaders to consider how the Medicare and Medicaid Services (CMS) proposal to make significant cuts to radiation oncology facilities could be detrimental to the survival of patients with Read more…
FDA Approves Neoadjuvant Pembrolizumab Combination for Early TNBC Indication
The FDA granted approval to the supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as neoadjuvant therapy for patients with high-risk early-stage triple-negative breast cancer (TNBC) when given in combination with chemotherapy followed by single-agent Read more…
Recommended TVUS Screening Thresholds May Miss Endometrial Cancer in Black Women
Adherence to current clinical guidelines for the evaluation of postmenopausal bleeding may result in systematic underdiagnosis of endometrial cancer (EC) in Black women, according to a study published online July 15 in JAMA Oncology. Kemi M. Read more…