AstraZeneca drug gets US FDA nod for certain type of endometrial cancer

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on Jun 17, 2024
Updated: Jun 18, 2024
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  • AstraZeneca's Imfinzi approved by FDA for combination chemotherapy in advanced endometrial cancer.
  • Clinical trials show Imfinzi reduces risk of disease progression or death by 58% in dMMR patients.
  • AstraZeneca aims for $80 billion in annual revenues by 2030, driven by oncology and new drug launches.

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AstraZeneca, the largest pharmaceutical group in Britain, announced that the U.S. Food and Drug Administration (FDA) has approved its lung cancer drug, Imfinzi, for use alongside other chemotherapy treatments.

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The approval is specifically for Imfinzi in combination with carboplatin and paclitaxel, followed by Imfinzi monotherapy. This regimen is intended for adults suffering from primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

Significant trial results

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The approval follows a clinical trial that demonstrated Imfinzi’s efficacy in reducing the risk of disease progression or death by 58% in patients with dMMR endometrial cancer compared to chemotherapy alone.

Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, emphasized the importance of this advancement.

There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future.

He highlighted that immunotherapy combined with chemotherapy is emerging as a new standard of care in this setting, and Imfinzi offers a crucial new option for patients with mismatch repair deficient disease.

Prevalence and impact of endometrial cancer

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Endometrial cancer is a significant health concern in the United States, being the fourth most common cancer in women. In 2022 alone, over 66,000 women were diagnosed with the disease, and nearly 12,000 deaths were attributed to it.

The approval of Imfinzi is seen as a major step forward in providing effective treatment options for these patients.

Broader implications for AstraZeneca

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The recent FDA approval is part of AstraZeneca’s broader strategy to enhance its oncology portfolio. The company has been focusing on developing treatments for various types of cancer, including highly aggressive small cell lung cancer.

In April, AstraZeneca revealed promising results for Imfinzi in treating this form of lung cancer, showing statistically significant and clinically meaningful improvement in patient survival.

In 2022, approximately 2.5 million lung cancer cases were diagnosed globally, highlighting the immense need for effective treatments.

AstraZeneca’s ongoing research and development efforts in oncology are critical to addressing this global health challenge.

Strategic growth targets

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AstraZeneca has set ambitious targets for future growth. In May, the company announced its goal to reach $80 billion in annual revenues by 2030. This objective is supported by the planned launch of 20 new medicines, which will bolster its existing portfolio.

Last year, AstraZeneca achieved a turnover of $45.8 billion, meeting a decade-long goal driven by rising demand for its oncology and diabetes treatments.

The company’s strategy includes increasing annual turnover by 75% by the start of the next decade through continued growth in its oncology, biopharmaceuticals, and rare disease portfolios.

This growth is expected to be driven by the successful development and commercialization of new treatments like Imfinzi.

How did the markets react?

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Despite the positive news of the FDA approval, AstraZeneca shares saw a slight decline, falling 0.26% to 12,478p in Monday morning trading. This market reaction could be influenced by broader market conditions or investor expectations.

AstraZeneca’s recent FDA approval for Imfinzi in combination with chemotherapy represents a significant advancement in the treatment of endometrial cancer.

This development underscores the company’s commitment to innovation in oncology and its strategic focus on expanding its portfolio to address critical health needs.

As AstraZeneca continues to pursue ambitious growth targets, its efforts in developing new cancer treatments are poised to make a substantial impact on global health outcomes.

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