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SMC reverses decision on Opdivo for kidney cancer

pharmafile | June 12, 2017 | News story | Manufacturing and Production, Sales and Marketing BMS, Bristol-Myers Squibb, SMC, opdivo 

The Scottish Medicines Consortium (SMC) has performed a U-turn on its decision regarding Opdivo (nivolumab), and will now allow patients suffering from advanced stages of kidney cancer to access the drug as part of routine treatment.

The reversal of a previous decision to reject the drug came after new data was submitted by Bristol-Myers Squibb that showed significant improvement on overall survival above standard targeted therapy.

The Phase 3 trial data showed that patients treated with Opdivo, after previous therapy was no longer effective, lived on average to 26 months against 19.7 months with standard therapy. BMS also noted that patients were able to live with an improved quality of life with fewer side-effects as a result of treatment.

The SMC’s decision comes over seven months after NICE had performed the same U-turn. However, patients in the US have had access to the drug for advanced renal cell carcinoma since November 2015 – a full two years prior to access in England and Wales.

 “This important decision will be welcome news for many patients with advanced kidney cancer,” commented Professor Rob Jones, Professor of Clinical Cancer Research, University of Glasgow. “By targeting the immune system to fight the cancer, nivolumab offers the potential to improve survival with a more favourable side effect profile compared to standard treatment. The use of a checkpoint inhibitor like nivolumab is a new mode of therapy in kidney cancer that offers a different way of treating this disease.”

Globally, rates of kidney cancer are rising; in Scotland, rates have risen by 25% over the last decade. As well as this, mortality rates in Scotland are also particularly high, with 1,100 new cases identified in 2014 and 490 people dying.

Kidney cancer is particularly difficult to treat due to the difficulties in diagnosing symptoms. At many times, the symptoms are general – unexplained weight loss, aches and pains – until the cancer has metastasised. Once metastasised, the prognosis for patients is often poor and this is why the approval of Opdivo could make a big difference to Scottish patients.

Ben Hargreaves

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