19th Aug 2024 09:31
(Alliance News) - Daiichi Sankyo Co Ltd on Monday announced positive updates for Enhertu, with the cancer drug receiving support from US and European regulators.
The Tokyo-based pharmaceutical giant said trastuzumab deruxtecan, better known as Enhertu, has been granted breakthrough therapy designation by the US Food & Drug Administration for adult patients with unresectable or metastatic hormone receptor positive HER2 low or HER2 ultralow breast cancer.
Daiichi Sankyo is jointly developing and commercialising Enhertu with Cambridge, England-based biopharmaceutical firm AstraZeneca PLC.
In the case of the US BTD award, Enhertu would be used to treat patients who have received either two lines of endocrine therapy in the metastatic setting; or one line of endocrine therapy if they had demonstrated disease progression within six months of starting first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor; or within 24 months of the start of adjuvant endocrine therapy.
Breakthrough therapy designation, Daiichi noted, "is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.
"The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines."
Daiichi Sankyo said the FDA granted the BTD based on data from the Destiny-Breast06 phase 3 trial, in which - as AstraZeneca announced in late April - Enhertu "demonstrated statistically significant and clinically meaningful improvement in progression-free survival".
"If approved, Enhertu could once again change the treatment paradigm for certain patients with breast cancer, pushing past old boundaries and broadening the number of people who may be eligible for a HER2 directed therapy," said Global Head of Research & Development Ken Takeshita. "The designation also showcases Daiichi Sankyo's commitment to pioneering cutting-edge science to deliver medicines like Enhertu that create new standards of care for patients with cancer."
At the same time, and also based on the Destiny-Breast06 trial, Daiichi announced that the European Medicines Agency validated its type 2 variation application for Enhertu as a monotherapy.
This would be to treat adult patients with unresectable or metastatic HER2 low or HER2 ultralow breast cancer, who have received at least one endocrine therapy in the metastatic setting.
"Validation confirms that the application is complete and commences the scientific review process by the EMA's Committee for Medicinal Products for Human Use," Daiichi Sankyo explained.
"This submission builds on our existing indication for Enhertu in patients with HER2 low metastatic breast cancer and an expanded approval would enable the potential for use in an earlier disease setting as well as in a broader patient population that now includes HER2 ultralow," Takeshita commented. "We look forward to working closely with the EMA to potentially bring this medicine to more patients in the EU."
Daiichi Sankyo shares closed down 3.3% at JPY5,766.00 in Tokyo on Monday. AstraZeneca shares were down 0.5% to 12,979.08 pence in London.
By Emma Curzon, Alliance News reporter
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