LONDON (ShareCast) - (Sharecast News) - AstraZeneca announced on Monday that it has secured approval from the US Food and Drug Administration, alongside Daiichi Sankyo, for 'Datroway', or datopotamab deruxtecan, a treatment for adult patients with previously treated, unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer.
The FTSE 100 pharmaceuticals giant said the approval was based on results from the TROPION-Breast01 phase three trial, which demonstrated a 37% reduction in the risk of disease progression or death compared to chemotherapy.

It said the trial showed that patients treated with Datroway experienced a median progression-free survival of 6.9 months, compared to 4.9 months for those receiving chemotherapy.

The hazard ratio for disease progression or death was 0.63, with a 95% confidence interval of 0.52 to 0.76 and a p-value of less than 0.0001.

It said the safety profile of Datroway was consistent with previous findings, with an interstitial lung disease rate of 4.2%, the majority of which were low grade.

Datroway is a TROP2-directed antibody drug conjugate that was discovered by Daiichi Sankyo and is being jointly developed and commercialised with AstraZeneca.

The approval marked the first for Datroway in the US, and would contribute to AstraZeneca's goal of delivering 20 new medicines by 2030.

Regulatory submissions for Datroway were meanwhile currently under review in the European Union, China and other regions.

"With this first approval of Datroway in the US, we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers," said Dave Fredrickson, executive vice-president of AstraZeneca's oncology haematology business unit.

"We are proud to bring Datroway to people living with metastatic HR-positive, HER2-negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030."

At 0847 GMT, shares in AstraZeneca were up 0.38% at 10,980p.

Reporting by Josh White for Sharecast.com.

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