What is Erbitux used to treat?
Cetuximab is a type of targeted cancer drug. It is also known by its brand name Erbitux. You might have it as a treatment for advanced bowel cancer and head and neck cancers that start in the mouth and throat.
Why did the FDA reject Erbitux?
At the core of the F.D.A.’s rejection of the Erbitux application is the fact that the clinical trials were not constructed in a way that shows the drug is an effective weapon against cancer on its own.
Is Erbitux chemotherapy?
ERBITUX with a type of chemotherapy called FOLFIRI (irinotecan, fluorouracil, leucovorin) was studied in a clinical trial of 1217 people with EGFR-expressing colorectal cancer that had spread (metastasized) to other parts of the body.
Does Erbitux cause hair loss?
ERBITUX may cause hair changes. Hair changes during EGFR treatment may: Make the eyelashes grow very fast and become very long and bother your eyes. Cause fast growth to eyebrows.
How successful is cetuximab?
Cetuximab also has activity as monotherapy in patients with recurrent and/or metastatic SCCHN who had failed platinum-based chemotherapy,. with a 12.6% response rate, disease control rate of 46%, and median response duration of ~ 6 months.
When was Erbitux approved by the FDA?
Use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Since its first approval in 2004, ERBITUX has more than seven years of experience in medical practice. Additionally, approximately 127,000 patients received ERBITUX therapy over that time period in the U.S. alone.
Who manufactures Erbitux?
Erbitux is a trademark owned by or licensed to Eli Lilly and Company , its subsidiaries, or affiliates.
How long is Erbitux treatment?
Subsequent doses: 250 mg/m² administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks). Complete ERBITUX administration 1 hour prior to radiation therapy.
Is Erbitux covered by Medicare?
The Centers for Medicare & Medicaid Services (CMS) will cover the use of oxaliplatin (Eloxatin™), irinotecan (Camptosar®), cetuximab (Erbitux™), or bevacizumab (Avastin™), in clinical trials identified by CMS and sponsored by the National Cancer Institute (NCI).
How effective is cetuximab?
What is the difference between the European and US versions of Erbitux?
ERBITUX results in approximately 22% higher blood levels of cetuximab as compared to the European version of ERBITUX. It is possible that U.S. patients receiving ERBITUX may experience more frequent or severe side effects than patients in the study conducted in Europe.
How is Erbitux administered in patients with Karnofsky disease?
Patients were administered intravenously a 20-mg test dose of ERBITUX on Day 1, followed by a 400 mg/m 2 initial dose, and 250 mg/m 2 weekly until disease progression or unacceptable toxicity. The median age was 57 years, 82% were male, 100% White, and 62% had a Karnofsky performance status of ≥80. The ORR was 13% (95% CI 7%, 21%).
For use alone to treat patients with a certain type of head and neck cancer whose tumor has returned in the same location or spread to other parts of the body and whose disease has progressed following platinum-based chemotherapy ERBITUX is available by prescription only. What is the most important information I should know about ERBITUX?