The U. S. pharmaceutical giant BMS (BMS) cancer immunization pipeline has recently heard a great deal of news in EU regulation. The European Medicines Agency (EMA) Committee for medicinal products for human use (CHMP) issued a positive opinion, recommending the approval of PD-1 immune therapy with Opdivo as a single drug therapy for head and neck squamous cell carcinoma during the progress of platinum based chemotherapy in the treatment of the disease or after treatment (SCCHN) for the treatment of adult patients.
Opdivo is also the first immunological oncology preparation that has been recommended by the European Union CHMP for platinum refractory SCCHN. In Europe, as of now, Opdivo has been approved for up to 6 indications in the treatment of 4 unique types of tumor.
In the US regulatory aspect, Opdivo was approved by FDA in November 2016 for the treatment of adult patients with platinum refractory recurrent or metastatic head and neck squamous cell carcinoma (SCCHN). This approval made Opdivo the first cancer immunotherapy in the US market to treat SCCHN, marking a major milestone in the clinical treatment of SCCHN.
Opdivo was approved by the United States FDA and the EU CHMP recommendation, based on data from key phase III clinical research (CheckMate-141). The study is an open label, randomized phase III study involving 361 patients with platinum refractory recurrent or metastatic head and neck squamous cell carcinoma (SCCHN) patients, study, patients were randomly assigned in a 2:1 ratio to Opdivo (3mg/kg, once every 2 weeks of intravenous therapy) or selected by researchers (cetuximab / MTX / docetaxel) toxicity caused by treatment until disease progression or unacceptable withdrawal. The main end point of the study was the total survival period (OS), and secondary endpoints included objective remission rate (ORR) and progression free survival (PFS).
According to the evaluation of the independent data monitoring committee (DMC), compared with the control group, the Opdivo treatment group showed significant superiority in total survival (OS) (median OS:7.5 months vs 5.1 months), and the mortality risk was significantly reduced by 30%.
At present, Opdivo has not yet been listed on the mainland of China, and patients who want to get the drug can only be purchased from the United States or Hongkong 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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