WILMINGTON, Del. - AstraZeneca (NASDAQ:AZN)'s supplemental Biologics License Application (sBLA) for IMFINZI (durvalumab) has been accepted by the U.S. Food and Drug Administration (FDA) with Priority Review status. This decision is based on the ADRIATIC Phase III trial results, which indicated a significant survival benefit in patients with limited-stage small cell lung cancer following chemotherapy and radiotherapy.
Priority Review is granted to drugs that may provide significant improvements in treatment efficacy or safety, address serious conditions, or enhance patient compliance. The FDA's decision is expected in the fourth quarter of 2024.
IMFINZI has also been awarded Breakthrough Therapy Designation, which expedites the development and review of drugs intended to treat serious conditions where there is an unmet medical need.
Small cell lung cancer (SCLC) is an aggressive cancer form that often progresses quickly after initial response to treatment. The prognosis for patients with limited-stage SCLC is poor, with a five-year survival rate of 15-30%.
The ADRIATIC Phase III trial demonstrated that IMFINZI reduced the risk of death by 27% compared to placebo. The median overall survival was 55.9 months for those treated with IMFINZI, compared to 33.4 months for the placebo group. Progression-free survival was also extended, with a 24% reduced risk of disease progression or death.
The safety profile of IMFINZI was consistent with its known effects, with no new safety concerns observed during the trial.
This news is particularly significant for patients with limited-stage small cell lung cancer, a group for whom treatment options have not substantially changed in decades. IMFINZI's potential as the first immunotherapy to show a survival benefit in this context could represent a significant advancement in the treatment landscape.
The information in this article is based on a press release statement from AstraZeneca.
In other recent news, AstraZeneca's cancer drug Imfinzi has been granted priority review status by the U.S. Food and Drug Administration (FDA) for the treatment of limited-stage small cell lung cancer. This follows the successful results from late-stage clinical trials. Simultaneously, the pharmaceutical giant secured €1.4 billion through a bond offering managed by BNP Paribas (OTC:BNPQY), Goldman Sachs International, Morgan Stanley, and Société Générale.
In addition, the company reported positive interim results from the AMPLIFY Phase III trial, indicating that its drug CALQUENCE® significantly improved progression-free survival in untreated chronic lymphocytic leukemia patients. Reflecting these developments, TD Cowen raised its stock price target on AstraZeneca's shares to $95 from the previous target of $90, maintaining a Buy rating for the stock.
Finally, AstraZeneca disclosed its total number of voting rights and share capital as of the end of July, in compliance with the UK's Financial Conduct Authority's Disclosure and Transparency Rules. These recent developments highlight the ongoing advances and achievements of AstraZeneca in the pharmaceutical industry.
InvestingPro Insights
AstraZeneca (NASDAQ: AZN) has garnered attention with its recent FDA Priority Review status for IMFINZI, highlighting its potential to impact the treatment of small cell lung cancer. As investors consider AstraZeneca's prospects, it's worth examining key financial metrics and analyst expectations.
InvestingPro Data shows AstraZeneca's Market Cap stands at a robust $260.15 billion, reflecting its substantial presence in the pharmaceutical industry. The company's Price/Earnings (P/E) Ratio is currently at 40.28, indicating a premium valuation which aligns with its status as a prominent player in the sector. The Revenue Growth over the last twelve months as of Q2 2024 is 10.45%, suggesting a healthy increase in the company's financial performance.
InvestingPro Tips highlight that analysts are predicting the company will be profitable this year, with net income expected to grow. This is a crucial consideration for investors looking at the company's future earnings potential. However, it's important to note that four analysts have revised their earnings downwards for the upcoming period, which might signal caution regarding short-term expectations.
For those seeking more comprehensive analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/AZN. These tips delve deeper into AstraZeneca's financial health, market position, and stock performance, offering valuable insights for investors making informed decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.