The FDA has granted accelerated approval to datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) for patients with previously treated EGFR-mutated non-small cell lung cancer (NSCLC), marking a significant advancement for patients who have exhausted standard treatment options.
Clinical Trial Results Drive Approval
The approval was based on compelling data from two pivotal trials: TROPION-Lung05 (NCT04484142) and TROPION-Lung01 (NCT04656652). In these studies, Dato-DXd demonstrated a 45% overall response rate with a median duration of response of 6.5 months in patients with EGFR-mutated NSCLC who had previously received both EGFR-targeted therapies and chemotherapy.
According to Balazs Halmos, MD, of Montefiore Einstein Comprehensive Cancer Center and Albert Einstein College of Medicine, the agent "offers a valuable option for patients who have progressed on both EGFR-targeted therapies and chemotherapy, a setting with limited treatment alternatives."
Addressing Unmet Medical Need
The approval specifically targets patients with advanced or metastatic EGFR-mutated NSCLC who have progressed after receiving EGFR-targeted therapies and chemotherapy. This represents a critical treatment gap, as patients in this setting have historically had few effective therapeutic options available.
Halmos emphasized that the observed activity "reinforces Dato-DXd's role in the EGFR-mutated NSCLC treatment sequence," positioning the drug as an important addition to the therapeutic armamentarium for this patient population.
Safety Profile and Monitoring Requirements
While Dato-DXd showed promising efficacy, the treatment requires careful monitoring for specific adverse effects. The most notable safety concerns include stomatitis and interstitial lung disease, both of which necessitate ongoing clinical surveillance.
Despite these monitoring requirements, Halmos noted that "the safety profile is manageable," suggesting that the benefit-risk profile supports the drug's use in this heavily pretreated patient population.
Clinical Impact
The accelerated approval of Dato-DXd represents a meaningful therapeutic advance for patients with EGFR-mutated NSCLC who have limited treatment options after progression on standard therapies. The 45% response rate observed in clinical trials provides hope for patients facing this challenging clinical scenario, where effective treatments have been scarce.
