Bristol Myers immunotherapy drug Opdivo (Nivolumab) by the U.S. FDA approval for the first qualification, treatment of patients with treatment of hepatocellular carcinoma

Bristol Myers Squibb recently announced that the FDA accepted Opdivo (Nivolumab) for hepatocellular carcinoma patients after treatment with sorafenib (HCC) supplemental biologics license application (sBLA), with the expansion of the application of Nivolumab in the treatment of liver cancer. FDA granted the application priority approval qualification, and before that, Nivolumab had been identified as an orphan drug granted by FDA for the treatment of hepatocellular carcinoma.

This application is based on the results of phase CheckMate-040 I/II clinical research. This study analyzed the application of Nivolumab in patients with advanced hepatocellular carcinoma who were infected or not infected with HBV or HCV. The recent data published in the "Lancet" magazine, and the upcoming 2017 American Society of Clinical Oncology (ASCO) poster session report (June 3, 2017 at 4:45-6:00 p.m. central daylight time).

Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer, and is also the second largest cause of cancer related death in the world. There are more than 70 new diagnosed patients with hepatocellular carcinoma in the world each year, nearly half of them in China. The disease is mainly due to hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, so HBV/HCV is the most common risk factor for liver cancer.

The diagnosis of hepatocellular carcinoma is often advanced, and the choice of treatment is limited and the prognosis is poor. The 1 - year survival rate of advanced hepatocellular carcinoma is about 44%. The median survival time for patients with hepatocellular carcinoma after sorafenib intolerance or in the period of Sola Fini's treatment is less than 11 months.

About Nivolumab

Nivolumab is a PD-1 immunologic checkpoint inhibitor that uniquely uses the body's own immune system to help the body restore the anti - tumor immune response. By using the human autoimmune system to fight cancer, Nivolumab has become an important treatment choice for various tumor types.

In July 2014, Nivolumab became the first PD-1 immune checkpoint inhibitor approved by regulatory agencies in the world. At present, Nivolumab has been approved in more than 60 regions, including the United States, the European Union and Japan. In October 2015, Nivolumab combined with Ipilimumab for the treatment of melanoma became the first combination therapy of immune tumor drugs approved by regulators. Now it has been approved in more than 50 regions, including the United States and the European Union.

Nivolumab indications approved by the US Food and Drug Administration (FDA)

Nivolumab single drug therapy can be used for the treatment of BRAF V600 mutation positive non resectable or metastatic melanoma. Based on the significant effect of Nivolumab on the progression free survival, the indication has been speeded up. According to the results of the clinical benefit of the confirmatory test, the continuing approval of the indication could be judged.

Nivolumab single drug therapy can be used for the treatment of BRAF V600 wild-type non resectable or metastatic melanoma.

Nivolumab combined with Ipilimumab is suitable for the treatment of patients with non resectable or metastatic melanoma. Based on the significant effect of the therapy on the progression free survival, the indication has been speeded up. The continuing approval of the indications will be judged on the basis of the results of the clinical benefit of the confirmatory test.

Nivolumab can be used for the treatment of metastatic non-small cell lung cancer (NSCLC) in the treatment of platinum chemotherapy and the treatment of advanced treatment for the treatment of progressed non - small cell lung cancer (NSCLC). For patients with EGFR mutation or ALK rearrangement, before using Nivolumab, we should confirm that patients have been progressed with FDA approved drugs for these gene abnormality.

Nivolumab can be used for the treatment of patients with advanced renal cell carcinoma (RCC) who had used antiangiogenic drugs.

Nivolumab can be used in autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin treatment or 3 line and multi line autologous hematopoietic stem cell transplantation after systemic therapy, relapse or progression of Adult Classic Hodgkin lymphoma (cHL). Based on the significant effect of the drug on the total remission rate, the indication has been speeded up. The continuing approval of the indications will be judged on the basis of the results of the clinical benefit of the confirmatory test.

Nivolumab can be used for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN) in the period of platinum chemotherapy or chemotherapy.

Nivolumab can be used in the treatment of patients with locally advanced or metastatic urothelial cancer within 12 months after platinum chemotherapy. Based on the significant effect of the drug on the remission rate and the duration of the reaction, the indication has been speeded up. The continuing approval of the indications will be judged on the basis of the results of the clinical benefit of the confirmatory test.

At present, Opdivo has not yet been listed on the mainland of China, and patients who want to get the treatment will only go to the United States or Hongkong to receive treatment through overseas channels. Hangzhou Health Management Co., Ltd. provides an overseas medical direct train to help patients travel to cost-effective medical institutions.

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