After submitting additional information to Germany on the drug nivolumab’s side effects and clinical data for the treatment of advanced melanoma submitted by the drug manufacturer, a German drug approval agency said it was now better able to balance overall survival with the drug’s side effects.
Nivolumab, a checkpoint inhibitor monoclonal antibody that blocks PD-1 and stimulates immune T-cells, was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in December 2014, about three months ahead of schedule, for the treatment of adults with advanced melanoma.
In an addendum, the German Institute for Quality and Efficiency in Health Care (IQWiG) said the new data “showed a hint of a considerable added benefit in female melanoma patients with BRAF V600 mutation-negative tumor, and an indication of a major added benefit in male patients.”
The German Institute for Quality and Efficiency in Health Care (IQWiG) completed a dossier assessment in October 2015 where it evaluated the drug’s added benefit for melanoma patients. Bristol-Myers recently added the new data on the medicine’s biological and clinical properties, leading IQWiG to re-assess the drug’s clinical effect in a more comprehensive way.
Previously, the dossier submitted by the drug company had shown that patients whose tumor is BRAF V600 mutation-negative may benefit from the drug depending on their gender. The new data also discusses the advantages of nivolumab over dacarbazine (a chemotherapy drug used for the treatment of several cancers, including malignant melanoma), noting the severe and serious side effects of dacarbazine.
The institute’s addendum now reports fewer side effects in nivolumab than previously thought. The IQWiG addendum also reports considerable added benefit in female melanoma patients with BRAF V600 mutation-negative tumour, instead of the precious reported “minor” benefit, and an indication of a major added benefit in male patients, an increase from the previously reported “considerable” benefit.
Under Germany’s rules of pharmaceutical approvals, IQWig presents the new information in the form of an addendum to the earlier dossier, then the German Federal Joint Committee (G-BA), the entity that comprises the agencies of the German healthcare system, will make a final decision on the extent of added benefit of the drug.