The FDA Approves a New Drug for Stage 4. Pancreatic Cancer

The FDA approved Onivyde for advanced (metastatic) pancreatic cancer. It is a liposomal form of the long-established chemotherapy irinotecan. Approval covers use with 5FU and leucovorin after previous gemcitabine-based chemotherapy.

An effective treatment after first-line gemcitabine chemotherapy had long been sought for advanced pancreatic cancer, without encouraging results until now.

Nanotechnology produced drugs have begun entering clinical practice. Onivyde is the 3. nanotechnology-produced chemotherapy to receive FDA approval; previously, Abraxane and Doxil were produced with this technology.

It was obtained by coating conventional irinotecan with liposomal micelles using nanotechnology.

The study leading to FDA approval, NAPOLI-1 , found that adding liposomal irinotecan to 5-FU and leucovorin increased median survival from 4,2 to 6,1 months. Liposomal irinotecan alone provided no significant survival benefit.

According to our country's 2015 data, pancreatic cancer is the 9. most common cancer in men. Most pancreatic cancers are adenocarcinomas. Before this study, many patients received gemcitabine-based treatment as adjuvant/neoadjuvant therapy for locally advanced disease or first- or second-line metastatic treatment, but suitable drugs after progression were unclear.

Liposomal irinotecan has FDA approval only and is not yet approved in our country. Following all cancer developments closely, we will announce domestic approval on our news page if granted.

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