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(Alliance News) - AstraZeneca PLC on Monday said its Truqap drug has been recommended for approval in the EU to treat a form of breast cancer, while also noting trial results for its Enhertu offering.
The Cambridge, UK-based pharmaceuticals manufacturer said, in combination with Faslodex, the Truqap recommendation comes from the Committee for Medicinal Products for Human Use, part of the European Medicines Agency.
It follows trial results which showed the drug combination "reduced the risk of disease progression or death by 50% versus Faslodex alone".
AstraZeneca noted that regulatory applications are currently under review in countries such as China, while similar indications for Truqap in combination with Faslodex are already approved in Japan, the US and other countries, based on results from the CAPItello-291 trial.
"Today's news reinforces the practice-changing potential of Truqap in combination with Faslodex to extend the effectiveness of endocrine-based treatment approaches for patients who experience tumour progression on, or resistance to widely used endocrine-based therapies," said AstraZeneca Executive Vice President for Oncology Research & Development Susan Galbraith.
"This recommendation recognises the high unmet need in this biomarker-specific patient population, and if approved, patients in Europe with this specific type of disease may be able to benefit from this first-in-class treatment option."
Separately, AstraZeneca said trial results showed its Enhertu offering, which it develops jointly with partner Daiichi Sankyo Co Ltd, "demonstrated a statistically significant and clinically meaningful improvement in progression-free survival" compared to standard chemotherapy in some breast cancer sufferers.
Progression-free survival is the length of time a sufferer of a disease lives without the disease worsening.
"The safety profile of Enhertu was consistent with previous breast cancer clinical trials with no new safety signals identified. The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities," it added.
Galbraith commented: "[The] Destiny-Breast06 [trial] shows that Enhertu could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."
Daiichi Sankyo Global Head of R&D Ken Takeshita commented: "The topline results from Destiny-Breast06 highlight the importance of continuing to challenge current treatment paradigms and established breast cancer classifications to evolve how we treat patients with HR-positive, HER2-expressing metastatic breast cancer. Building on the practice-changing data seen in Destiny-Breast04, these results reinforce the potential for use of Enhertu earlier in the treatment landscape and in an even broader patient population."
Shares in AstraZeneca were up 0.8% to 12,104.00 pence each in London on Monday morning, while Daiichi Sankyo closed up 5.1% to JPY5,010.00 each in Tokyo.
By Greg Rosenvinge, Alliance News senior reporter
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