U.S FDA approves Enhertu for advanced gastric cancer treatment
Category: #health  By Pankaj Singh  Date: 2021-01-20
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U.S FDA approves Enhertu for advanced gastric cancer treatment

•             US FDA approves breast cancer drug Enhertu for the treatment of few types of advanced gastric cancers

•             The approval was based on the outcomes from phase II DESTINY-Gastric01 clinical trial conducted in South Korea and Japan

AstraZeneca Plc. and Daiichi Sankyo Company Limited have reportedly announced that their breast cancer drug named ‘Enhertu’ has received regulatory approval from the U.S FDA (Food and Drug Administration) for the treatment of few types of gastric cancers.

As per sources, both companies are using biomarker-based drugs for the treatment of patients with rare tumors. Notably, AstraZeneca made an approximately USD 7 billion bet on the new cancer therapy when it collaborated with Daiichi in a direct challenge to Roche in 2019.

Sources cite that this treatment has been approved as a therapy for priorly-treated advanced HER2-positive gastric cancer patients. The British-Swedish multinational pharmaceutical and biopharmaceutical company added that it owes around USD 115 million in milestones to Daiichi for the recent indication.

Speaking on which, Dave Fredrickson who is the executive VP at AstraZeneca’s oncology business unit stated that the approval of Enhertu highlights the first advanced HER2-directed therapy approved in the last ten years for HER2-positive metastatic gastric cancer patients.

Apparently, in the United States, gastric cancer is often diagnosed in the advanced stage with only around 5% of patients surviving for more than five years.  Nearly one out of five gastric cancer patients are HER2 positive and over 26,000 people in the U.S are anticipated to become gastric cancer positive this year, according to American Cancer Society estimates.

The British firm has said that U.S. FDA approval was based on the outcomes from the DESTINY-Gastric01 Phase II randomized clinical trial conducted in South Korea and Japan. In the clinical trial, the treatment showcased a meaningful improvement and statistically considerable improvement in OS (Overall survivor) and ORR (Objective Response Rate) against chemotherapy in advanced gastric cancer patients who had undergone previous treatments.

Source credit - https://www.reuters.com/article/us-astrazeneca-cancer-enhertu/astrazeneca-daiichis-breast-cancer-drug-gets-broader-u-s-approval-idUSKBN29N0JP



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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