AstraZeneca (NASDAQ:AZN) stated that the FDA has approved and prioritized its new drug application (NDA) for capivasertib in combination with Faslodex (fulvestrant). The combination is being sought for approval to treat adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have recurred or progressed on or after an endocrine-based therapy.

The FDA’s verdict is expected in the fourth quarter of 2023.

Priority review is given to candidates that, if approved, would offer considerable advantages over existing choices in terms of safety or efficacy, preventing serious conditions, or improving patient compliance.

AstraZeneca shares have gained 8.9% this year, above the industry’s 0.8% increase.

Furthermore, AstraZeneca’s NDA for the capivasertib/Faslodex combination is being reviewed under Project Orbis, a new FDA initiative that provides a framework for concurrent submission and review of oncology medicines among participating international partners with the goal of expediting approval for patients worldwide.

The NDA was based on positive findings from the company’s phase III CAPItello-291 study, which compared capivasertib in combination with Faslodex to placebo plus Faslodex for the treatment of locally advanced or metastatic HR-positive, HER2-low or negative breast cancer. In the whole patient group, the trial found a 40% reduction in the risk of disease progression or mortality when compared to placebo + Faslodex.

The overall survival (OS) data were considered immature at the time of the study analysis. AstraZeneca, on the other hand, continues to evaluate OS as a primary secondary endpoint in the research. Furthermore, the capivasertib/Faslodex combination’s safety profile was found to be consistent with that observed in earlier studies examining this combination.

AstraZeneca’s oral therapy candidate is capivasertib, a possible adenosine triphosphate-competitive inhibitor that is currently in numerous mid-late-stage studies for treating a variety of cancer diseases. Faslodex is licensed in numerous countries for the treatment of breast cancer, either as a monotherapy or in combination with CDK4/6 and PI3K inhibitors.

We would like to remind investors that the FDA approved the capivasertib/Faslodex combination fast-track designation for the same indication in January 2023. When preliminary nonclinical and clinical evidence shows that the medicine may demonstrate significant improvement over available therapies to address unmet medical needs for serious or life-threatening illnesses, the FDA’s fast-track designations are intended to speed development and review timelines. The fast track tag allows for close collaboration between the FDA and the sponsor in order to optimize product development efficiency and get innovative therapies to patients faster.

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