FDA Grants Accelerated Approval to Datroway for Previously Treated EGFR-Mutated Lung Cancer

The FDA has granted accelerated approval to Datroway (datopotamab deruxtecan) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation whose disease has progressed following treatment with an EGFR-targeted therapy and platinum-based chemotherapy, according to a June 23 announcement from AstraZeneca and Daiichi Sankyo.

Lung cancer is the leading cause of cancer-related death worldwide, with NSCLC accounting for approximately 87% of cases. EGFR mutations are found in approximately 10% to 15% of NSCLC tumors in the U.S. and Europe. Although targeted therapies have improved outcomes for many patients with EGFR mutations, most eventually develop resistance and have limited treatment options in later lines of therapy, with docetaxel-based chemotherapy as the current standard of care.

Datroway is the first approved therapy in the U.S. that targets TROP2, a cell surface protein expressed in certain tumors, including NSCLC. The accelerated approval is based on overall response rate and duration of response in clinical trials, and continued approval may depend on confirmatory results from ongoing studies.

In the phase 2 TROPION-Lung05 trial, published in January 2025 in the Journal of Clinical Oncology, Datroway showed an objective response rate of 45% among 114 patients previously treated for advanced EGFR-mutated lung cancer. About 4% of patients had a complete response and 40% had a partial response. The median duration of response was 6.5 months.

Overall survival results from the phase 3 TROPION-Lung01 trial further supported the approval. The study, published September 2024 in the same journal, compared Datroway to docetaxel in 590 patients with advanced lung cancer who had received prior therapy. Among patients with EGFR mutations, all had previously received both a targeted agent and chemotherapy. The results showed that, compared to docetaxel, Datroway helped people live longer without their cancer getting worse (progression-free survival of 4.4 months vs. 3.7 months). The Datroway group also had a slight improvement in overall survival (12.9 months vs. 11.8 months), although this difference wasn’t statistically significant. People with a certain type of lung cancer called nonsquamous NSCLC seemed to benefit the most.

Datroway is an antibody-drug conjugate that links a TROP2-targeting antibody to a topoisomerase inhibitor. The drug was initially approved in January 2025 for adults with HR-positive, HER2-negative breast cancer that cannot be removed by surgery or has spread and who have already had hormone therapy and chemotherapy.

Datroway is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The companies are also investigating Datroway in earlier lines of therapy and in combination with Tagrisso (Osimertinib) in two ongoing phase 3 trials, TROPION-Lung14 and TROPION-Lung15.

The recommended dosage of Datroway is six milligrams per kilogram of body weight (up to 540 mg for people who weigh 90 kg or more). It’s given as an IV infusion once every three weeks, with treatment continuing until the disease progresses or side effects become intolerable. The prescribing information for Datroway includes warnings about possible serious side effects, such as lung inflammation, eye problems, mouth sores, and risks of fetal harm.