Micrograph showing a non-small cell lung carcinoma. Credit: Librepath.

AstraZeneca and its partner Daiichi Sankyo have received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for Enhertu (trastuzumab deruxtecan) to treat non-small cell lung cancer (NSCLC).

Approval is for patients with metastatic NSCLC tumours having a HER2 mutation with disease progression on or following platinum-based treatment.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Enhertu is a HER2-directed ADC that delivers cytotoxic chemotherapy to cancer cells through a linker attached to a monoclonal antibody that binds to a target expressed on cancer cells.

In the US and Japan, the drug has the approval to treat adults with a specific type of unresectable or metastatic HER2-positive breast cancer.

AstraZeneca and Daiichi Sankyo partnered in March last year for the development and commercialisation of the drug globally, except in Japan where Daiichi Sankyo has exclusive rights.

Daiichi Sankyo Oncology R&D oncology development global head and senior vice-president Gilles Gallant said: “We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.”

FDA breakthrough status is supported by results from the ongoing Phase II DESTINY-Lung01 trial in patients with HER2-mutant (HER2m) metastatic NSCLC, as well as a completed Phase I trial.

During the DESTINY-Lung01 trial, the drug’s overall safety and tolerability profile were found to be consistent with that of the Phase I trial.

Last week, the drug secured BTD in the US for patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma after two or more prior regimens including trastuzumab.

In 2017, Enhertu secured BTD for HER2-positive metastatic breast cancer and received approval in December.