(Alliance News) - AstraZeneca PLC and Daiichi Sankyo Co Ltd on Monday said that the European Medicines Agency has approved two marketing authorisation applications for their datopotamab deruxtecan in two types of cancer.

AstraZeneca and Daiichi are both pharmaceutical companies, based in Cambridge and Tokyo respectively.

The first of the applications is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer. The second is for the treatment of adults with unresectable or metastatic hormone receptor positive or HER2-negative breast cancer, who have progressed on and are not suitable for endocrine therapy.

The applications are based on data from the Tropion-Lung01 and Tropion-Breast01 phase three trials, the firms said.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo, and is being jointly developed by AstraZeneca and Daiichi Sankyo.

The companies added that additional regulatory submissions for datopotamab deruxtecan in lung cancer and breast cancer are underway in the US and globally.

Daiichi Sankyo's Global Head of Research & Development Ken Takeshita said: "The EMA validation is an important first step toward bringing this TROP2-directed antibody drug conjugate to eligible patients in Europe with nonsquamous lung cancer and HR-positive, HER2-negative breast cancer.

"This news builds on our recent regulatory progress in the US, where our lung cancer application has been accepted and our breast cancer application is underway, underscoring our commitment to changing the standard of care by developing new medicines to help as many patients worldwide as possible."

Seperately on Monday, Daiichi Sankyo said its marketing alliance agreement with Mitsubishi Tanabe Pharma Corp for its DPP-4 inhibitor tablets, under the brand name Tenelia, will expire in September. The marketing deal for its SGLT2 inhibitor or Canaglu tablets will also expire that month.

Under the agreement, Daiichi Sankyo has been in charge of distributing Tenelia tablets, while Canaglu has been distributed by Mitsubish Tanabe Pharma.

Following the expiration of the marketing alliance agreement, Daiichi Sankyo will transfer the distribution rights of Tenelia to Mitsubishi Tanabe Pharma.

Mitsubishi Tanabe Pharma is an Osaka, Japan-based subsidiary of Mitsubishi Chemical Holdings Corp.

Shares in AstraZeneca were broadly flat at 10,076.00 pence each in London on Monday morning, while Daiichi Sankyo shares closed down 1.9% at JPY4,902.00 in Tokyo.

By Sabrina Penty, Alliance News reporter

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