Melanoma adjuvant treatment! The four week dose regimen (Q4w) of Bristol Myers Squibb opdivo has been recommended and approved in the European Union!

September 25, 2019 / BIOON / - Bristol Myers Squibb (BMS) recently announced that the European Drug Administration (EMA) human pharmaceutical products Committee (CHMP) has issued a positive review opinion, recommending and approving two drug delivery schemes of opdivo (odivo, common name: nivolumab, nevuliumab), which are used for melanoma with lymph node involvement or metastasis The adjuvant treatment of patients after complete resection is as follows: (1) the drug regimen of 240 mg dose infusion for more than 30 minutes every 2 weeks (q2w); (2) the drug regimen of 480 mg dose infusion for more than 60 minutes every 4 weeks (Q4w) The CHMP's comments will now be submitted to the European Commission (EC), which is expected to make a final review decision in about two months Ralu Vlad Pharm D., head of BMS product design and delivery development team, said: "CHMP's positive comments on opdivo's 2-week and 4-week drug delivery programs strengthen our commitment to providing patients, caregivers and healthcare providers with flexible drug delivery options We look forward to the decision of the European Commission to bring this new opdivo regimen to patients as soon as possible " According to the in situ characteristics, thickness and ulceration degree of the tumor, whether the tumor spreads to the lymph node or not, and whether the tumor spreads beyond the lymph node, the melanoma can be divided into five stages (0-4 stages) Stage 3 melanoma has reached the local lymph nodes, but has not spread to the distant lymph nodes or other parts of the body (metastasis) Surgery is needed to remove the primary tumor and related lymph nodes Some patients can also receive adjuvant treatment Despite surgical intervention and adjuvant treatment, most patients will experience relapse and metastasis In clinical, the effective treatment of tumor has always been surgical resection, except for surgery, the treatment is called adjuvant treatment, its purpose is to eliminate the remaining small metastasis after surgery, reduce the chance of tumor recurrence and metastasis, and improve the cure rate Early intervention with adjuvant therapy has been shown to be an important factor in reducing the risk of postoperative recurrence of high-risk stage 3 melanoma Opdivo belongs to PD-1 / PD-L1 immunotherapy, which is a kind of anti-cancer immunotherapy that attracts much attention at present It aims to use the human body's own immune system to resist cancer, and block the PD-1 / PD-L1 signal pathway to make cancer cells die It has the potential to treat various types of tumors Approved in July 2014, opdivo is the first PD-1 immunotherapy approved globally Up to now, the drug has been approved by more than 60 countries around the world and has become an important treatment option for a variety of cancers In October 2015, opdivo + yervoy immunocombination therapy was approved as the first immunooncology combined therapy for metastatic melanoma, which has been approved in more than 50 countries In terms of melanoma, the approved indications of opdivo include: (1) as a single drug therapy for patients with unresectable or metastatic melanoma; (2) combined with yevoy for patients with unresectable or metastatic melanoma; (3) adjuvant therapy for patients with lymph node involvement or metastatic melanoma who have been completely removed Source of the original text: Bristol Myers Squibb receives positive CHMP opinion recommending approval of Opera (nivolumab) four week doing schedule for the adjust treatment of adult patients with melody with involvement of lymph nodes or metastatic release who have