The checkpoint inhibitor nivolumab continues to confirm its superiority on chemotherapy docexatel in advanced squamous non-small-lung cancer. As recent studies proved survival benefits, data presented at the European Cancer Congress (ECC2015) in Vienna, showed that the patients’ health status improved during the first year of treatment, in terms of quality of life and perceived symptoms.
According to Sanjay Popat of the Royal Marsden Hospital NHS Foundation Trust in London, UK, results from the phase III CheckMate 017 trial will have a huge impact on clinical practice, wiping out all concerns for potential drug toxicity.
Abstract 3011: Evaluation of overall health status in patients with advanced squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 017
M. Reck, C. Coon, F. Taylor, M. DeRosa, J.R. Penrod, H. Dastani, L. Orsini, R.J. Gralla
EMA Recommends Extension of Therapeutic Indications for Nivolumab
New indication concerns locally advanced or metastatic squamous NSCLC after prior chemotherapy
On 24 September 2015 the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product nivolumab (Opdivo).
The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The CHMP adopted a new indication as follows:
“Non-Small Cell Lung Cancer (NSCLC) Opdivo is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.”
For information, the full indications for Opdivo will be as follows:
“Melanoma Opdivo as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Non-Small Cell Lung Cancer (NSCLC) Opdivo is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.”
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.