FDA grants Opdivo breakthrough status for kidney cancer
pharmafile | September 18, 2015 | News story | Research and Development, Sales and Marketing | BMS, Breakthrough Therapy Designation, Bristol-Myers Squibb, FDA, Kidney cancer, immuno-oncology, immunotherapy, nivolumab, opdivo, renal cell carcinoma
The FDA has given Bristol-Myers Squibb’s immuno-oncology drug Opdivo Breakthrough Therapy Designation as a kidney cancer treatment.
The FDA’s decision is based on data from BMS’ CheckMate series of studies of Opdivo (nivolumab). The studies have marked the earliest any checkpoint inhibitor has proven itself in a kidney cancer trial. The drug met its primary endpoint by demonstrating an overall survival benefit in patients with metastatic renal cell carcinoma (RCC).
Michael Giordano, BMS’ senior vice president and head of development, oncology, says: “Results from CheckMate-025 mark the third tumour in which Opdivo has shown an overall survival benefit in a Phase III trial. The Breakthrough Therapy Designation in advanced renal cell carcinoma is a clear signal of the need for additional treatment approaches for RCC and reflects part of our broad commitment to immuno-oncology research that may address many types of advanced cancers.”
The Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.
Last July, Bristol-Myers Squibb premature ended a late-stage study that found Opdivo had positively in patients with advanced kidney cancer. This is thought to be the fourth Breakthrough Therapy Designation granted for Opdivo by the FDA.
Bristol-Myers Squibb will be presenting further data from this study at the upcoming 2015 European Cancer Congress (ECC).
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