We have just learnt that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), is recommending approval of pembrolizumab for the adjuvant treatment of people with intermediate to high risk renal cell carcinoma (RCC) following nephrectomy.
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The European Commission will review the drug’s potential marketing authorisation, and is expected to make a final decision in the first quarter of 2022.
Adjuvant therapy is medication that is given in addition to surgery to try to prevent the cancer from coming back. Adjuvant therapy can be used to kill any remaining microscopic cancer cells, or it can control the growth of any remaining cancer.
This recommendation is based on the results from the phase 3 KEYNOTE-564 trial where adjuvant pembrolizumab significantly reduced the risk of the cancer returning by about one third (32%) compared to placebo. This is the first positive phase 3 study of adjuvant immunotherapy used for the treatment of intermediate to high risk RCC.
Pembrolizumab is currently approved by several health authorities around the world for use in combination with axitinib as a first medication for patients with advanced RCC. Also, pembrolizumab is currently being assessed by the National Institute for Health and Care Excellence (NICE) for use within the NHS in England and Wales.