AstraZeneca and Daiichi Sankyo today, August 5, 2022, obtained an approval in the United States that expands the use of their Enhertu therapy for patients with breast cancerand paves the way for multi-million dollar sales.
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This is the first US Food and Drug Administration (FDA) approval for a treatment specifically targeted at patients with so-called HER2-low breast cancer, the agency reported.
The breast cancer can express, at different levels, a protein called HER2 that contributes to its growth and spread.
Tumors with low levels of HER2 are defined as those whose cells contain lower levels of the HER2 protein on their surface.
The approval in the United States is based on data from an late-stage trial involving more than 550 patients with HER2-low breast cancer – most with hormone-sensitive tumors – whose disease had spread and who had received at least one round of chemotherapy.
The data, presented at a scientific conference in June to a standing ovation from the public, showed that Enhertu prolonged survival by an additional 6.4 months in patients with hormone-sensitive tumors.
The small group of patients with hormone-insensitive tumors who received Enhertu lived 6.3 months longer.
The treatment also nearly doubled the time it took before patients with hormone-sensitive disease began to worsen, a measure known as progression-free survival (PFS).
Nevertheless, Enhertu comes with some major security issues.
Enhertu must carry a boxed warning – the FDA’s most serious – to highlight the risk of a type of lung scarring and toxicity to the fetus, the regulator said Friday, adding that the therapy is not recommended for women. pregnant.
The drug belongs to a class of therapies called antibody drug conjugates (ADCs). Enhertu consists of a monoclonal antibody – in this case trastuzumab (also known as Herceptin) – chemically linked to a cell-killing chemotherapy drug.
Enhertu It originally obtained approval in the United States in late 2019 as a third-line treatment for the 15% of breast cancer patients with HER2-positive disease.
The new approval – which comes months before the FDA’s expected decision date – opens up a vast new patient population and the prospect of billions in additional revenue for its manufacturers.
Enhertu it generated sales of $214 million in 2021. AstraZeneca took partial rights to the compound from Daiichi Sankyo three years ago in a deal worth as much as $6.9 billion.
The FDA estimates that about 287,850 new cases of breast cancer will be diagnosed in women this year.
Approximately 80% to 85% of these new cases will be in patients who express little or no HER2. Of these, 60% are considered HER2-low.
With information from Reuters