The novel pegylated liposomal formulation of irinotecan (formerly known as MM-398, marketed as Onivyde by Shire Pharmaceuticals, licensed from Merrimak) has been recommended for approval in the European Union for use in the treatment of metastatic pancreatic cancer. It is indicated for use in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in adult patients who have experienced disease progression following treatment with gemcitabine-based therapy.
This product was approved in the United States in October 2015.
The recommendation for approval was based on results from the pivotal phase 3 trial known as NAPOLI-1, which showed a survival benefit, as reported by Medscape Medical News. In that trial, all patients were treated with 5-FU 2400 mg/m2 and LV 400 mg/m2, but in those patients who also received the pegulated liposomal irinotecan product, median overall survival was significantly improved (8.9 vs 5.1 months; hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.29 - 0.77; P = .0018).
The most common side effects with the product are diarrhea, nausea, vomiting, decreased appetite, neutropenia, fatigue, asthenia, anemia, stomatitis, and pyrexia, according to the European Medicines Agency.
The manufacturer notes that in September 2015, the European Society of Medical Oncology (ESMO) stated that use of pegylated irinotecan, when available in all countries, may be the best option for second-line treatment of these patients following gemcitabine-based therapy. Gemcitabine-based therapy is commonly used as a first-line treatment for patients with metastatic disease or locally advanced disease who cannot be treated with surgery; it is also used as adjuvant therapy.
"Guidance from ESMO indicates the use of Onivyde for the treatment of metastatic pancreatic cancer in patients who have progressed following gemcitabine-based treatment," commented Volker Heinemann, MD, PhD, professor of medical oncology at the University of Munich, Germany, in the company press release.
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