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Enhertu Granted BTD In US For HER2-mutant Metastatic Non-small Cell Lung Cancer

AstraZeneca Plc. (AZN.L,AZN) said that and Daiichi Sankyo Co.'s (DSKYF.PK) Enhertu has been granted Breakthrough Therapy Designation in the US for the treatment of patients with metastatic non-small cell lung cancer or NSCLC whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.

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

The Food and Drug Administration's Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.

The overall safety and tolerability profile of Enhertu in the ongoing DESTINY-Lung01 trial is consistent with that seen in the Phase I trial. The most common adverse events to date are gastrointestinal and haematological including nausea, alopecia, anaemia, decreased appetite and decreased neutrophil count.

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