FDA say Opdivo is a Breakthrough in Kidney Cancer

Image and video hosting by TinyPicBristol-Myers Squibb (BMS) moves closer to approval of its checkpoint inhibitor Opdivo in kidney cancer after obtaining FDA ‘breakthrough’ status for the cancer immunotherapy in that indication.

The designation comes after Opdivo (nivolumab) was shown to be effective as a treatment for renal cell carcinoma in a phase III trial reported in July.

The CheckMate-025 study compared BMS’ drug to Novartis’ Afinitor (everolimus) in RCC and showed a clear survival advantage in an interim analysis, prompting the company to stop the trial early and switch all patients over to Opdivo.

The study marked the first time a checkpoint inhibitor was shown to be effective in RCC and also the first time that any drug had extended survival versus Afinitor, the standard therapy for this type of solid tumour.

Breakthrough designation means that Opdivo will get an expedited review at the FDA, extending its lead in that indication compared to rival checkpoint inhibitor Keytruda (pembrolizumab) from Merck & Co, which is in early-stage trials for RCC.

Michael Giordano, head of development, oncology, at BMS, said: “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.”

Opdivo is already approved for melanoma and squamous non-small cell lung cancer (NSCLC) and achieved sales of $162m in the first six months of the year. Keytruda is currently only approved for melanoma but was first to market in the US for that indication and brought in $192m in that period. It has been filed for NSCLC and could claim a slightly broader label than Opdivo if approved.

BMS’ lead in follow-up indications is expected to allow it to pull ahead of rivals in the checkpoint inhibitor market, despite looming competition from AstraZeneca, Roche and Merck KGaA/Pfizer.

The FDA is reviewing marketing applications for Opdivo as a first-line monotherapy for melanoma and as a combination with BMS’ Yervoy (ipilimumab), as well as for previously treated non-squamous NSCLC.


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