AstraZeneca Share Price Rose 1.7% on US FDA Approval of Truqap

The AstraZeneca plc (LON: AZN) share price rose 1.70% after its Truqap (capivasertib), in combination with Faslodex (fulvestrant), received approval from the United States Food and Drug Administration (FDA) for the treatment of adult patients diagnosed with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer.

The target patients should also have one or more specific biomarker alterations (PIK3CA, AKT1, or PTEN). Eligible patients must have experienced disease progression after at least one endocrine-based treatment in the metastatic setting or have had a recurrence within 12 months of completing adjuvant therapy.

The FDA's decision was based on the findings of the CAPItello-291 Phase III trial, which were published earlier this year in The New England Journal of Medicine. 

In this clinical trial, the combination of Truqap and Faslodex demonstrated a 50% reduction in the risk of disease progression or death compared to Faslodex alone in patients with tumours with specific PI3K/AKT pathway biomarker alterations. 

Breast cancer ranks as the most prevalent cancer and is one of the leading causes of cancer-related mortality worldwide. Hormone receptor-positive breast cancer, characterised by the presence of estrogen or progesterone receptors, is the most common subtype, accounting for over 65% of cases that are HER2-low or HER2-negative. 

Among these patients, mutations in PIK3CA, AKT1, and alterations in PTEN are frequent, affecting as many as 50% of those with advanced HR-positive breast cancer. 

While endocrine therapies are commonly used in this context, many patients eventually develop resistance to first-line cyclin-dependent kinase (CDK) 4/6 inhibitors and estrogen receptor-targeting therapies, highlighting the importance of additional endocrine therapy-based treatment options.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The rapid US approval of Truqap reinforces the important role of the PI3K/AKT pathway in HR-positive breast cancer and the critical need to test patients at the time of diagnosis, as up to fifty per cent have tumours with these alterations. As a first-in-class medicine, this approval provides a critical new option for patients in the US with this specific type of disease, and we look forward to bringing Truqap to the many breast cancer patients who can benefit across the globe.”

AstraZeneca (AZN) share price. 

The AstraZeneca share price rose 1.70% to trade at 10330.0p from Thursday’s closing price of 10157.0p.