The US Food and Drug Administration (FDA) has approved a new lung cancer treatment developed by AstraZeneca, the British–Swedish pharmaceutical group headquartered in Cambridge, and its Japanese partner Daiichi Sankyo.
The therapy, Datopotamab deruxtecan (to be marketed as Datroway), is an antibody–drug conjugate (ADC) that targets the protein TROP2. It has been authorised for use in adults with non-small cell lung cancer (NSCLC) who carry EGFR mutations and have experienced disease progression after existing treatments, including targeted therapies and chemotherapy.
This is the second ADC to result from the strategic oncology partnership between AstraZeneca and Daiichi Sankyo. Research and development for the drug has been led from AstraZeneca’s Cambridge Biomedical Campus - a key hub in the UK’s growing life sciences sector.
“Patients with this form of lung cancer have limited options after resistance develops to standard therapies,” commented Dave Fredrickson, Executive Vice President, Oncology, at AstraZeneca. “This FDA approval reflects our commitment to delivering new treatment approaches with targeted ADCs.”
Datroway works by attaching a toxic chemotherapy payload to an antibody that locates and binds to cancer cells expressing TROP2, reducing off-target toxicity to healthy tissue.
Financial and regulatory implications
As part of a 2020 joint development agreement between the two companies, the approval triggers a milestone payment of approximately £35 million (USD $45 million) from AstraZeneca to Daiichi Sankyo.
The broader collaboration could be worth up to £4.7 billion (USD $6 billion), dependent on future regulatory and commercial milestones.
Although this week’s decision applies to the US market, the approval is likely to accelerate regulatory submissions in other territories. AstraZeneca is expected to engage with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and NICE, raising the prospect of NHS access for eligible patients in the future.
Industry outlook
The approval strengthens AstraZeneca’s growing ADC portfolio, which also includes Enhertu and other pipeline assets targeting solid tumours. The company has become a key player in the global ADC space - a therapeutic class increasingly seen as central to the next wave of cancer drug development.
Further studies of Datroway are underway in other cancers where TROP2 is expressed, including certain breast and gastrointestinal cancers.
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