AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of non-small cell lung cancer (NSCLC) patients.
The antibody drug conjugate has been authorised for use in adults with locally advanced or metastatic EGFR-mutated NSCLC who have previously received EGFR-directed therapy and platinum-based chemotherapy, making it the first and only TROP2-directed therapy approved in the US for lung cancer.
The FDA’s decision on the drug was based on positive results from a subgroup analysis of the mid-stage TROPION-Lung05 trial and supported by data from the late-stage TROPION-Lung01 trial.
In the studies, Datroway showed a confirmed objective response rate of 45% in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC. Complete responses and partial responses were observed in 4.4% and 40% of patients, respectively, and the median duration of response was 6.5 months.
In line with the FDA’s accelerated approvals pathway, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The American Cancer Society estimated that approximately 226,650 people will be diagnosed with lung cancer in the US this year, with NSCLC accounting for around 87% of cases.
For the 10% to 15% of NSCLC patients in the US who have an EGFR mutation, the established first-line treatment in the metastatic setting includes EGFR-directed therapy with or without platinum-based chemotherapy. However, the majority of patients will eventually experience disease progression and require subsequent therapies.
Datroway belongs to a relatively new class of cancer drugs that combine the selectivity of antibodies with the potent cell-killing power of chemotherapy or other anti-cancer agents.
The drug, which is already approved in the US to treat certain cases of breast cancer, was discovered by Daiichi Sankyo and is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation.”