FDA Grants Label Expansion to AstraZeneca's Datroway in Lung Cancer

AstraZeneca AZN announced that the FDA has expanded the label of its cancer drug Datroway for a second indication — non-small cell lung cancer (NSCLC). The drug has been developed in partnership with Japan-based Daiichi Sankyo.

The FDA approved Datroway under the accelerated pathway to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior systemic therapies, including an EGFR-directed therapy.

This approval came within six months of the drug’s first FDA approval in breast cancer indication. The agency’s decision is supported by data from two clinical studies — the phase II TROPION-Lung05 study and the phase III TROPION-Lung01 study — which showed that treatment with Datroway achieved an objective response rate (ORR) of 45%.

Following the label expansion, the AstraZeneca-Daiichi drug became the first TROP2-directed therapy approved in the United States for lung cancer. Datroway was granted breakthrough therapy designation by the FDA in this indication last December.

AZN Stock Performance

Year to date, AstraZeneca’s shares have gained 8% against the industry’s 3% decline.

More on AZN’s Datroway

Datroway is the second antibody-drug conjugate (ADC) drug developed under the AstraZeneca-Daiichi partnership, the first being the blockbuster Enhertu. Per the terms of the partnership, both companies are jointly responsible for developing and marketing the drugs worldwide, except in Japan, where Daiichi maintains exclusive rights for both. Daiichi is also responsible for the manufacturing and supply of both Enhertu and Datroway.

AZN and partner Daiichi are currently evaluating Datroway in an extensive clinical development program, both as monotherapy and in combination with other drugs across multiple cancer indications, including breast and lung cancers. This includes eight late-stage studies across lung cancer indications and five in breast cancer.

Per AstraZeneca, Datroway is part of a select group of therapies that could achieve peak annual sales of at least $5 billion. These medicines are part of the company’s ambitious growth strategy to achieve $80 billion in annual revenues by 2030.

ADCs like Enhertu and Datroway are being considered disruptive innovations in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.

AZN’s Zacks Rank

AstraZeneca currently carries a Zacks Rank #3 (Hold).

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Some better-ranked stocks from the sector are Immunocore IMCR and Agenus AGEN. While IMCR sports a Zacks Rank #1 (Strong Buy) at present, AGEN carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, loss per share estimates for Immunocore’s 2025 have improved from $1.50 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained nearly 6% year to date.

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This article originally published on Zacks Investment Research (zacks.com).

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