The US Food and Drug Administration has issued an incredibly speedy approval for the use of Bristol-Myers Squibb’s immunotherapy Opdivo in patients with advanced renal cell carcinoma, marking its fifth regulatory approval across three tumour types in the country.
The move – which comes just a week after the regulator said it would undertake a priority review with a target date in March next year – also marks clearance of the first and only PD-1 inhibitor to show a significant overall survival benefit in patients with advanced RCC who have received prior anti-angiogenic therapy, BMS noted.
In the Phase III trial Checkmate-025, patients receiving Opdivo (nivolumab) achieved overall survival of 25 months versus 19.6 months for those taking Novartis’ Afinitor (everolimus), a current standard of care for this population. Also, 21.5 percent of those treated with BMS’ drug experienced a complete or partial shrinkage of their tumours, which lasted an average of 23 months, compared to 3.9 percent of those taking Afinitor, lasting an average of 13.7 months.
On the downside, the most common adverse events linked with Opdivo in kidney cancer patients are conditions relating to abnormal weakness or lack of energy, cough, nausea, rash, difficulty breathing, diarrohea, constipation, decreased appetite, back pain and joint pain (arthralgia), and the drud can also cause serious immune-mediated side effects, the agency noted.
Opdivo works by targeting the cellular pathway known as PD-1/PD-L1, to help the body’s immune system fight cancer cells.
As such, it offers physicians and patients a new approach that has the potential to provide “an unprecedented survival advantage compared to a standard of care,” said Francis Cuss, the firm’s chief scientific officer.
The drug is also on the US market as a treatment for melanoma and non-small cell lung cancer, which “demonstrates how immune therapies can benefit patients across a wide range of tumours,” commented Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
