HQ Team
December 9, 2024: The US regulator has granted a breakthrough therapy designation to British-Swedish AstraZeneca and Japan’s Daiichi Sankyo experimental drug for treating a certain type of lung cancer.
The Food and Drug Administration approved datopotamab deruxtecan (Dato-DXd), which followed “encouraging” end-stage and supporting trial data, which enrolled more than 700 patients.
“Datopotamab deruxtecan showed a 42.7% objective response rate in previously treated patients,” according to a statement.
The FDA’s nod is given to accelerate the development and regulatory review of potential new medicines that are intended to treat serious conditions and address significant unmet medical needs.
The medicine must show encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
Antibody-drug conjugate
Dato-DXd is meant to treat adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.
The drug is an antibody-drug conjugate or a specialised drug designed to target and kill cancer cells while minimising damage to healthy cells.
It was discovered by Daiichi Sankyo and is being jointly developed by AstraZeneca and Daiichi Sankyo.
It is used for patients with disease progression on or after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor and platinum-based chemotherapy.
Epidermal growth factor-tyrosine kinase inhibitors are a type of medication used to treat certain types of lung cancer that have specific genetic mutations. They help stop cancer cells from growing.
Chemotherapy
Over time, some patients may find that their cancer continues to progress despite being treated with these inhibitors. This means the initial treatment is no longer effective.
After the cancer progresses, doctors often recommend switching to platinum-based chemotherapy.
This type of chemotherapy uses drugs like cisplatin or carboplatin, which can be more effective for patients whose cancer has become resistant to earlier treatments.
AstraZeneca and Daiichi Sankyo in November submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan.
The move came after they voluntarily withdrew an earlier BLA in the US for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous non-small cell lung cancer based on an end-stage trial.
Unmet medical needs
“This Breakthrough Therapy Designation reinforces datopotamab deruxtecan as a promising potential therapy for patients with epidermal growth factor receptor-mutated lung cancer who continue to face significant unmet needs following disease progression on or after initial treatments,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca.
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including negative breast cancer.
The programme includes seven late-stage trials in lung cancer and five late-stage trials in breast cancer evaluating datopotamab deruxtecan as a monotherapy and in combination with other anticancer treatments in various settings.
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 80% of cases.
About 10 to 15% of patients with non-small lung cancer in the US and Europe and 30 to 40% of patients in Asia have a mutation.
