AstraZeneca and Daiichi cancer drugs clear regulatory hurdles

(Alliance News) - AstraZeneca PLC on Friday announced one approval and two recommendations for three products, for different cancer indications, in the US and EU.

The Cambridge-based pharmaceutical company's drug camizestrant, in combination with a cyclin-dependent kinase 4/6 inhibitor, has been recommended for approval in the EU.

This is for adults with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer, upon detection of ESR1 mutation and without disease progression during 1st-line endocrine therapy in combination with a CDK4/6 inhibitor.

AstraZeneca said the recommendation was based on results from the "pivotal" Serena-6 phase 3 trial. Interim analysis found that the camizestrant combination reduced the risk of disease progression or death by 56% versus standard-of-care treatment, and improved the median rate of progression-free survival.

Also on Friday, Astra and Tokyo-based pharmaceutical major Daiichi Sankyo Co Ltd announced that Enhertu, or trastuzumab deruxtecan, has been recommended for EU approval as a monotherapy for adults with unresectable or metastatic HER2-positive solid tumours. The patients will have received prior treatment and will have been left with no satisfactory treatment options.

They said the European Medicines Agency's Committee for Medicinal Products for Human Use based its positive opinion on results from a subgroup of patients with HER2-positive tumours across the Destiny-PanTumor02, Destiny-Lung01, and Destiny-CRC02 phase 3 trials.

They said Enhertu "demonstrated clinically meaningful responses across a broad range of tumours" in these studies.

Finally, Astra and Daiichi announced that Datroway, or datopotamab deruxtecan, has been approved in the US for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

They said this followed the US Food & Drug Administration granting Datroway priority review, based on results from the Tropion-Breast02 phase 3 trial.

Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival, and a 43% reduction in patients' risk of disease progression or death, when compared with chemotherapy.

Daiichi Sankyo Chief Executive Ken Keller commented: "As the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, Datroway has the potential to redefine the treatment landscape for these patients.

"With this approval, Datroway is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumour types."

AstraZeneca shares were down 0.2% at 13,984.00 pence on Friday in London. Daiichi Sankyo shares closed 0.6% lower at JPY2,649.50 in Tokyo.

By Emma Curzon, Alliance News reporter

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