(RTTNews) - 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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