The move indicates that in patients with unknown or negative Rearranged during Transfection (RET) mutation, a lower benefit should be considered prior to individual treatment decisions.
Clinical data has demonstrated that Caprelsa has benefited patients irrespective of their RET status.
AstraZeneca will conduct a further study to generate additional data to confirm the benefits in patients who are RET negative, in accordance with CHMP’s requirement.
The CHMP provided the opinion after reviewing data from the Phase III Caprelsa clinical trial programme, including the ZETA study.
The double-blind trial of 331 patients with advanced MTC that has progressed and spread to other parts of the body, showed a 54 % reduction in risk for disease progression compared to placebo.
The European Commission will now review the positive opinion for Caprelsa by CHMP.