AstraZeneca PLC and Daiichi Sankyo Co Ltd on Friday said their drug conjugate Enhertu has been approved for patients in the US with unresectable or metastatic non-small cell lung cancer.
Enhertu’s generic name is trastuzumab deruxtecan. It is a specifically engineered HER2-directed antibody drug conjugate and is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
It can now be used for ‘adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by a US Food & Drug Administration approved test, and who have received a prior systemic therapy,’ AstraZeneca said.
The Cambridge-based company explained that the FDA’s accelerated approval was based on results from a Phase II trial, which saw the drug have a response rate of just shy of 58%.
Following US approval, AstraZeneca will pay $125 million to Daiichi Sankyo as a ‘milestone’ payment, it added.
Earlier this week, Enhertu was approved for use for patients with HER2-low breast cancer, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
‘Enhertu has now been approved in three different tumour types, underscoring its significant potential across several HER2-targetable tumours. We are continuing to evaluate the efficacy and safety of Enhertu versus standard chemotherapy in our Destiny clinical trials in lung cancer,’ said Ken Keller, global head of Oncology Business at Tokyo-based Daiichi Sankyo.
AstraZeneca shares were up 0.6% at 10,570.00 pence each in London on Friday morning. Daiichi Sankyo shares closed up 1.2% at JP¥3,677 in Tokyo.
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