AstraZeneca and Daiichi Sankyo’s new antibody drug conjugate, Datroway (datopotamab deruxtecan), has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic EGFR‑mutated non‑small cell lung cancer (NSCLC) who have previously received EGFR‑directed therapy and platinum‑based chemotherapy . This marks the first U.S. approval of a TROP2‑directed therapy for lung cancer.

Why this matters to patients

For patients whose disease has progressed despite first‑line EGFR inhibitors and chemotherapy, options have been scarce. In clinical trials, Datroway demonstrated a confirmed objective response rate (ORR) of 45 percent, including complete responses in 4.4 percent and partial responses in 40 percent of participants. The median duration of response was 6.5 months, offering meaningful disease control in a setting where later‑line treatments often yield limited benefit .

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The FDA’s Priority Review and Breakthrough Therapy Designation were granted on the strength of the Phase II TROPION‑Lung05 subgroup analysis and supporting Phase III TROPION‑Lung01 data . Continued approval will depend on confirmatory trials to verify and describe clinical benefit.

“Addressing disease progression in patients with advanced EGFR‑mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later‑line treatment options available. The US approval of datopotamab deruxtecan introduces a novel and needed treatment option to patients with advanced disease.”
— Jacob Sands, MD, Dana‑Farber Cancer Institute

“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.”
— Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca

“With today’s accelerated approval, Datroway is now the first TROP2‑directed medicine available for certain patients in the US living with lung cancer.”
— Ken Keller, Global Head of Oncology Business, Daiichi Sankyo, Inc

“For people with advanced EGFR‑mutated non‑small cell lung cancer whose disease progresses on initial treatments, additional options are limited. Today’s approval of Datroway offers a new treatment option…”
— Andrea E. Ferris, President and CEO, LUNGevity

Key facts at a glance

• Indication: Adults with locally advanced/metastatic EGFR‑mutated NSCLC after prior EGFR‑directed therapy and platinum‑based chemotherapy.
• Approval basis: Accelerated approval on ORR and duration of response; confirmatory trials pending.
• Efficacy: 45 percent ORR; median DoR 6.5 months.
• Safety: Consistent with known profile; no new safety concerns.

What it means for the public

Patients across the GCC with EGFR‑mutated NSCLC now have hope for a new treatment if first‑line therapies fail. While access and reimbursement will vary by country, the FDA’s green light often paves the way for regulatory submissions and patient access programs globally.