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AstraZeneca and Daiichi Sankyo receive FDA approval for lung cancer drug

A phase 2 trial demonstrated an overall response rate of 57.7% in patients with non-small cell lung cancer


AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu has been approved by the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC).

Enhertu (trastuzumab deruxtecan) has been approved for patients whose tumours have activating HER2 mutations, and who have received a prior systemic therapy.

The accelerated approval was based on results from the DESTINY-Breast02 phase 2 trial, in which Enhertu demonstrated a confirmed overall response rate of 57.7% in patients with previously treated unresectable or metastatic non-squamous HER2-mutant NSCLC.

Results from the trial also showed complete responses in 1.9% of patients and partial responses in 55.8%. In the analysis, the safety profile of Enhertu was consistent with previous clinical trials and no new safety concerns were identified.

Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is diagnosed at an advanced stage in nearly 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.

There are treatment options available for those diagnosed with stage 3 NSCLC, however if a patient progresses to stage 4 – otherwise known as metastatic cancer – the options available are often limited to the prolonging of life and palliative care provisions.

Enhertu belongs to a class of therapies called antibody drug conjugates, and consists of a HER2 monoclonal antibody chemically linked to a cell-killing chemotherapy drug.

Commenting on the approval, Dave Frederickson, executive vice president, Oncology Business Unit, AZ, said: “HER2-mutant NSCLC is an aggressive form of disease which commonly affects young patients who have faced limited treatment options and a poor prognosis to date.

“Today’s news provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease.”

Earlier this month, Enhertu was granted FDA approval for the treatment of adults with unresectable or metastatic breast cancer expressing low levels of HER2, a newly defined subset of HER2-negative breast cancer.

AZ and Daiichi Sankyo also announced promising results from its joint phase 1b trial assessing datopotamab deruxtecan (Dato-DXd) in patients with advanced non-small cell lung cancer (NSCLC).

Article by
Emily Kimber

12th August 2022

From: Research, Regulatory



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