FDA Approved Irinotecan Liposomal Injection Combined with Fl

Release time:2017-11-02 13:40:50

      FDA Approved Irinotecan Liposomal Injection Combined with Fluorouracil and Formyl Tetrahydrofolate for Advanced Pancreatic Cancer

       On October 22, the US FDA approved the combination of irinotecan liposomal injection (Onivyde) with fluorouracil and formyl tetrahydrofolate for the treatment of advanced (metastatic) pancreas cancer patients treated with gemcitabine-based chemotherapy.

       According to the information provided by the US National Cancer Institute in 2015,  the United States will have 4.896 million new cases of pancreatic cancer diagnosed, about the same number of cases (40.56 million) will die from the disease. Pancreatic cancer may be difficult to diagnose in early stage, and its treatment options are limited. Especially when the disease spreads to other parts of the body (metastatic disease), the surgical resection of the tumor is not possible.

       "A number of FDA reviewers who reviewed the drug were also Clinician, so when they could obtain new therapeutic agents more quickly for the patients not satisfied with the treatment, they felt a sense of accomplishment." Said Pazdur, MD, director of the Office of Hematology and Cancer Products at the Center for Drug Evaluation and Research at the FDA."By preferentially granting the        eligibility to appear on the market, patients will be able to obtain a drug that will help extend the survival time earlier."

       FDA awarded Irinotecan liposomal injection priority review and orphan drug qualification. Priority review qualification will granted to those if been approved they will have a significant improvement in the safety and efficacy of serious illness treatment. Orphan drug eligibility can provide incentives such as tax credit, applicant fee waiver and orphan drug franchise eligibility to help and encourage the development of rare disease drugs.

       The effectiveness of irinotecan liposomal injection was demonstrated in a three-group, randomized, open study. Subjects were 417 patients with metastatic pancreatic cancer and have accepted the treatment with gemcitabine or a gemcitabine-based therapy.

       The aim of this study was to make it clear that compared with patients treated with difluoroxiridine/leucovorin whether the patients accepting the treated with Irinotecan liposomal injection and fluorodipoxol / formyl tetrahydrofolate or just irinotecan lipids will alive longer.

       The average survival time of patients treated with irinotecan liposomal + fluorouracil / formyl tetrahydrofolate was 6.1 months. In contrast, patients treated with difluoroxidine / formyl tetrahydrofolate had an average survival time of 4.2 months. PatientS only treated with irinotecan liposomal injections did not improve their survival compared to those treated with diflosepoxide / formyl tetrahydrofolate.

       In addition, patients treated with irinotecan liposomal + fluorodepidine / formyl tetrahydrofolate had a time delay in tumor growth compared to patients treated with diflosoxir / formyl tetrahydrofolate. Patients receiving irinotecan liposuction + fluorodioxan / formyl tetrahydrofolate had an average delayed tumor growth of 3.1 months while patients receiving diflosoxir / formyl tetrahydrofolate had an average tumor growth delayed by 1.5 months.

       The safety of irinotecan liposomal injections has got the evaluation from the 398 patients who has received the treatment of irinotecan liposomal injection + fluorodipoxin / formyl tetrahydrofolate or just irinotecan liposomal injection monotherapy or just fluorodipoxin / formyl tetrahydrofolate treatment. The most common side effects of irinotecan liposomal injections are diarrhea, fatigue, vomiting, nausea, loss of appetite, oral inflammation (stomatitis) and fever.

       Irinotecan liposomal injections have also been found to result in reduced anti-infective cell counts (lymphopenia and neutropenia). It was reported that some patients with irinotecan liposomal injection therapy have caused death with neutropenia, thrombocytopenia.

       The label of irinotecan liposomal injection contains a black box warning to remind health care professionals about the risk of severe neutropenia and diarrhea in the drug. Irinotecan liposomal injection was not approved as a single drug for patients with metastatic pancreatic cancer. Irinotecan liposomal injection was marketed by Merrimack Pharmaceuticals in Cambridge, Massachusetts.