BMS receives priority review from FDA for Opdivo
BMS’s Opdivo is on track to add resected high-risk advanced melanoma to its current list of indications, after receiving a priority review from the US FDA.
The regulatory agency has already granted Opdivo breakthrough therapy designation for this setting, marking its seventh such designation.
Murdo Gordon, Chief Commercial Officer at BMS, said: “Priority review of our sBLA and granting of breakthrough designation are positive steps forward in our goal to address the high unmet need that exists among patients with resected advanced melanoma, many of whom experience disease recurrence.”
If approved, the PD-1 immune checkpoint inhibitor, which is designed to utilise the body’s immune system to fight cancer, could treat patients with skin cancer that are at high risk of disease recurrence following complete surgical restriction.
According to BMS, despite surgical intervention and possible adjuvant treatment, the majority of patients with skin cancer experience disease recurrence and progress to metastatic disease, with the majority of stage IIIb and IIIc patients (68% and 89%, respectively) experience disease recurrence after five years.
However, disease recurrence was BMS’ primary endpoint in its randomised, double-blind phase III CheckMate-238 study, which evaluated Opdivo in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma.
The study claimed Opdivo ‘significantly’ decreases the risk of disease recurrence compared to BMS’ own Yervoy (Ipilimumab), the current standard of care for stage III adjuvant melanoma.
To date, Opdivo has ten approved indications in the US, including non-small cell lung cancer (NSCLC), advanced renal cell carcinoma (RCC) and classical Hodgkin lymphoma (cHL).