AstraZeneca (AZN) Breast Cancer Combo Drug Gets Priority Review
AstraZeneca AZN announced that its new drug application (NDA) for capivasertib in combination with Faslodex (fulvestrant) has been accepted and granted priority review by the FDA. The NDA is seeking approval of the combination for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.
A decision from the FDA is expected in the fourth quarter of 2023.
The FDA grants priority review to candidates that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
So far this year, shares of AstraZeneca have gained 8.9% compared with the industry’s 0.8% rise.
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Furthermore, AstraZeneca’s NDA for the capivasertib/Faslodex combo is being reviewed under a new initiative by the FDA, Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners with the aim of speedy approval for patients around the world.
The NDA submission was based on positive results from the company’s phase III CAPItello-291 study, which evaluated the efficacy of capivasertib in combination with Faslodex against placebo plus Faslodex for the treatment of locally advanced or metastatic HR-positive, HER2-low or negative breast cancer. The study demonstrated a 40% reduction in the risk of disease progression or death compared with placebo plus Faslodex in the overall patient population.
At the time of the study analysis, the overall survival (OS) data was considered immature. However, AstraZeneca continues to assess OS in the study as a key secondary endpoint. Additionally, the safety profile of the capivasertib/Faslodex combination was found to be consistent with that observed in previous studies evaluating this combination.
Capivasertib, a potential adenosine triphosphate-competitive inhibitor, is AstraZeneca’s oral treatment candidate, which is currently under several mid-late-stage studies for treating several oncology indications. Faslodex is approved for the treatment of breast cancer in several countries, either as a monotherapy or in combination with CDK4/6 and PI3K inhibitors.
We would like to remind the investors that in January 2023, the FDA granted the capivasertib/Faslodex combo fast-track designation for the same indication. The FDA’s fast-track designations intend to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions. The fast track tag enables close communication between the FDA and sponsor to improve the efficiency of product development to get new therapeutics to patients faster.
AstraZeneca PLC Price and Consensus
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Zacks Rank and Stocks to Consider
AstraZeneca currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Novartis NVS, Akero Therapeutics AKRO and Adaptimmune Therapeutics ADAP, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Novartis’ 2023 earnings per share has increased from $6.55 to $6.72. During the same period, the estimate for Novartis’ 2024 earnings has increased from $7.04 to $7.26. So far this year, shares of Novartis have gained by 10.2%.
NVS beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 5.15%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.66 to $3.32. So far this year, shares of Akero Therapeutics have gained 1%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has remained stable at 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 74 cents to 56 cents. So far this year, shares of Adaptimmune Therapeutics have fallen by 28.8%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
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