Bristol-Myers Squibb (BMS) has secured approval from the European Commission (EC) for melanoma drug Opdivo (nivolumab) two and four-week flat dosing schedule.
The FDA has approved Opdivo flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused over 60 minutes every four weeks (Q4W) to serve as adjuvant treatment for adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Melanoma is a form of skin cancer that can be identified by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin.
It is divided into five staging categories, including 0- IV, based on the in-situ feature, thickness and ulceration of the tumour.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, which will help enhance the body’s own immune system to restore anti-tumour immune response.
Opdivo’s global development programme is comprised of a range of clinical trials across all phases in a variety of tumour types.
At present, Opdivo was approved in over 65 countries, including the US, the European Union, Japan and China.
In October 2015, the Opdivo and Yervoy combination regimen secured regulatory approval to treat metastatic melanoma. This indication is currently secured approval in over 50 countries.
BMS product design and delivery development team lead Dr Ralu Vlad said: “The approval of Opdivo two and four-week flat dosing schedule in the adjuvant melanoma setting is an important milestone for patients across the European Union who now have additional treatment flexibility.
“Bristol Myers-Squibb is committed to empowering patients with cancer and their families to regain control of their lives through more flexible treatment options that fit their individual needs.”
CheckMate -227 is a multi-part open-label phase 3 trial designed to assess Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced NSCLC cross non-squamous and squamous tumour histologies.