WILMINGTON, Del. - AstraZeneca (NASDAQ:AZN)'s supplemental New Drug Application (sNDA) for TAGRISSO (osimertinib) has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) following chemoradiotherapy. The FDA's decision is expected by the fourth quarter of 2024.
The Priority Review status is assigned to applications for medications that could significantly improve the treatment, diagnosis, or prevention of serious conditions. TAGRISSO has also received Breakthrough Therapy Designation in this setting, which aims to expedite the development and review of drugs intended to treat serious conditions and fill unmet medical needs.
Based on the results of the LAURA Phase III trial, TAGRISSO demonstrated a significant improvement in median progression-free survival (PFS), extending it by more than three years compared to placebo. The trial showed an 84% reduction in the risk of disease progression or death (hazard ratio [HR] 0.16; 95% confidence interval [CI] 0.10-0.24; p
While overall survival (OS) data from the trial are not yet mature, there is a favorable trend for TAGRISSO. Safety results were consistent with the known profile of the drug, and no new safety concerns were identified.
TAGRISSO is already approved in over 100 countries for several indications related to NSCLC, including first-line treatment, treatment after progression on prior therapy, and as adjuvant therapy following tumor resection.
In the United States alone, nearly 200,000 people are diagnosed with lung cancer annually, with NSCLC being the most prevalent form. Approximately 15% of these patients have EGFR mutations, and nearly one in five newly diagnosed cases are unresectable.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the importance of the Priority Review for TAGRISSO in providing a targeted treatment option for patients with no current alternatives and expressed the company's commitment to working closely with the FDA to bring this medication to patients as swiftly as possible.
This article is based on a press release statement from AstraZeneca.
In other recent news, AstraZeneca has been garnering attention with its consistent presence at the American Society of Clinical Oncology (ASCO) plenary sessions and successful trial results. The company's trials include AVANZAR, DESTINY-Breast09/11, and TROPION-Breast02, which have been positively evaluated by Citi. BMO (TSX:BMO) Capital has also upheld its Outperform rating on AstraZeneca, citing the successful outcomes of three Phase 3 trials, DESTINY-BREAST06, LAURA, and ADRIATIC.
These results are expected to expand the Total Addressable Markets (TAMs) for AstraZeneca's drugs Enhertu, Tagrisso, and Imfinzi. Deutsche Bank (ETR:DBKGn) maintained a 'Hold' rating on AstraZeneca after the ASCO oncology conference, emphasizing the company's continuous advancements in oncology. Argus increased the price target for AstraZeneca shares due to recent drug approvals and strategic acquisitions.
Goldman Sachs (NYSE:GS) initiated coverage on AstraZeneca, issuing a 'Buy' rating based on the company's robust pipeline and business fundamentals. BMO Capital reiterated an 'Outperform' rating following the announcement of overall survival results from the TROPION-Lung01 clinical trial. Lastly, JPMorgan (NYSE:JPM) maintained an 'Overweight' rating on AstraZeneca shares, buoyed by the potential of AZD0780 to generate multi-billion dollar peak sales.
InvestingPro Insights
As AstraZeneca (AZN) anticipates the FDA's decision on TAGRISSO for treating non-small cell lung cancer, the company's financial health and market performance could influence investor confidence. Here are some key insights based on the latest data from InvestingPro:
InvestingPro Data indicates AstraZeneca's market capitalization stands strong at 248.05 billion USD, reflecting its significant presence in the pharmaceutical industry. The company's P/E ratio, as of the last twelve months leading up to Q1 2024, is at 29.71, which is high and suggests that investors are expecting high earnings growth relative to the company's share price. Additionally, AstraZeneca has shown a solid revenue growth of 8.6% during the same period, which is a positive sign for potential investors looking at the company's ability to increase earnings.
InvestingPro Tips highlight that AstraZeneca is expected to see net income growth this year, with two analysts having revised their earnings estimates upwards for the upcoming period. Furthermore, the company has been recognized for its low price volatility and has maintained dividend payments for 32 consecutive years, which could be attractive for investors seeking stability and consistent returns.
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