AZ/Daiichi Sankyo's Enhertu picks up third breakthrough designation

AstraZeneca's and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with a particular form of lung cancer.

The award relates to the drug's development for metastatic non-small cell lung cancer (NSCLC) in patients whose tumours have an HER2 mutation and with disease progression on or after platinum-based therapy.

The firms note that NSCLC is the most common type of lung cancer and that prognosis is particularly poor for patients with metastatic disease, as only about 6-10% will be alive five years after diagnosis. Around 2-4% of patients with NSCLC have a HER2 mutation.

“Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress,” said José Baselga, AZ' executive vice president, R&D Oncology.

“We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation,” added Gilles Gallant, senior VP, global head, Oncology Development, Oncology R&D, Daiichi Sankyo. “We look forward to working closely with the FDA on the potential for Enhertu to become the first HER2-directed therapy approved for non-small cell lung cancer.”

This is the third BTD granted for Enhertu in the US, following its designations for HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have received two or more prior regimens including trastuzumab, and for HER2-positive metastatic breast cancer.