FDA Approves Amgen Drug for Most Deadly Form of Lung Cancer

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FDA Gives Green Light to Amgen's Drug for Small Cell Lung Cancer Treatment
The Amgen logo is displayed outside Amgen headquarters on May 17, 2023 in Thousand Oaks, California. Mario Tama/Getty Images

Amgen Inc. has received approval from the US for a new drug that offers hope to patients with an aggressive form of advanced lung cancer.

FDA Fast-Tracks Amgen's Drug for Tough Lung Cancer Cases

Amgen's drug is one of the limited options available for patients with small cell lung cancer whose tumors are no longer responsive to chemotherapy.

The US Food and Drug Administration (FDA) has granted accelerated approval to this treatment, allowing it to reach the market quickly to meet the urgent needs of patients.

This decision was based on a study that demonstrated its effectiveness in reducing tumor size in approximately 40% of patients who had previously tried other treatments without success.

Approximately 35,000 Americans receive a diagnosis of small cell lung cancer each year, a type of cancer that grows quickly and is strongly linked to previous smoking habits, Bloomberg reported.

Many cases have spread extensively by the time they are discovered, and although chemotherapy can be effective initially, the cancer typically returns aggressively, leaving patients with limited treatment choices. That's why there is a lot of enthusiasm among cancer doctors regarding Amgen's drug, Imdelltra.

Despite having completed only two out of the three stages of human testing typically required for approval and without evidence of extending patient survival, there is still excitement surrounding this drug.

Imdelltra's Cost and Efficacy in Treating Aggressive Lung Cancer

In accordance with Amgen, the cost of Imdelltra in the United States is $31,500 for the initial cycle and $30,000 for subsequent infusions. After a year of treatment, the total cost would amount to $781,500.

Participants in the study had a median survival of 14.3 months, which is significantly longer than the typical survival rate of about five months.

The majority of lung cancer cases are non-small cells, with a smaller percentage being the more aggressive small cell type that Imdelltra focuses on, as stated by the American Cancer Society.

According to Yahoo News, during the clinical trials, it was observed that the treatment had a notable side effect known as cytokine release syndrome.

This condition can be potentially dangerous as it occurs when the body's immune system responds excessively to infection or immunotherapy drugs.

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