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Medicines licensing

Nivolumab recommended for advanced kidney cancer by European Medicines Agency

Nivolumab (Opdivo) has been recommended for the treatment of advanced renal cell carcinoma in adults by the European Medicines Agency (EMA).

The drug was originally recommended for approval by the EMA for the treatment of advanced melanoma in June 2015 and in October gained its backing as a treatment for the advanced stages of squamous non-small cell lung cancer.

The EMA’s latest recommendation, announced on 26 February 2016, follows the results of a randomised phase III trial, which compared nivolumab with another kidney cancer treatment everolimus. The study involved 821 patients with locally advanced or metastatic renal cell carcinoma whose disease worsened during or after treatment with anti-angiogenic therapy.

The median survival time after starting treatment in patients taking nivolumab was 25 months compared with just under 20 months in patients treated with everolimus. Tumours in 22% of patients taking nivolumab were either completely or partially shrunk compared with 4% of those taking everolimus, with the effect lasting for around 12 months in both groups.

Nivolumab is a monoclonal antibody that targets the programmed death-1 (PD-1) receptor, which in turn activates the immune system against cancer cells.

The recommendation by the EMA’s committee for Medicinal Products for Human Use comes just two weeks after the product was made available for the same condition under the UK government’s early access to medicines scheme (EAMS).

The EAMS, launched in March 2015, allows patients with life-threatening or debilitating conditions access to promising drugs that have not yet completed the official licensing process.

A positive scientific opinion under the EAMS lasts 12 months. If the product receives a marketing authorisation during that time, it loses its EAMS status, and traditional marketing authorisation conditions apply.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20200798

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Supplementary images

  • Renal cell carcinoma

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