Amgen’s Drug for Small Cell Lung Cancer Receives US FDA Approval

Recently, the U.S. Food and Drug Administration (FDA) approved Imdelltra, a new therapeutic agent from Amgen, for people with advanced small-cell lung cancer (SCLC), a very aggressive form of the disease. Known generically as tarlatamab, Imdelltra is developed as a later line of treatment, meaning it can be administered if the cancer progresses after one or more other forms of treatment, such as chemotherapy. This approval represents significant progress for patients suffering from this malignant tumor.
Small-cell lung cancer (SCLC) is a subtype of lung cancer, representing approximately 15% of the 2.2 million cases globally, which sums to 330,000 cases worldwide. In the United States, almost 30,000 people are diagnosed with SCLC annually. This cancer is well-known for its high growth rate and early metastasis, typically presenting a large tumor and a series of severe symptoms such as bloody sputum, cough, chest pain, and breathing difficulty. The prognosis for SCLC patients is grim, with only 3% of those whose cancer has spread surviving more than five years.

Imdelltra represents Amgen’s bispecific T-cell engagers, which utilize the body’s immune system against cancer. The medication works by connecting cancer cells with T-cells (a type of immune cell), allowing the T-cells to recognize and kill the cancerous cells. This mechanism is crucial because it addresses an aggressive disease with limited treatment options.
Clinical trials for Imdelltra have shown promising outcomes. In a phase 2 study of over 200 patients treated with 10 mg every fortnight, 40% of the patients experienced significant tumor shrinkage. The median overall survival for patients treated with Imdelltra was 14.3 months, nearly three times the mean survival time of five months with regular therapies. During this extended period, patients have the opportunity to focus on meaningful life activities and improve their social connections.
A patient named Lynne Bell from Atlanta, Georgia, best describes the effects of the new treatment. Diagnosed with a very advanced stage of SCLC in 2021, Bell turned to Imdelltra after all other therapies had been unsuccessful. Since starting the trial, the drug has shown great effectiveness, with her tumors shrinking and her overall condition improving, with reduced pain and better cancer scans. Bell’s story emphasizes that Imdelltra can significantly improve patient outcomes.

Another SCLC survivor and advocate from Illinois, Maida Mangiameli, also expressed her enthusiasm regarding Imdelltra’s approval. Diagnosed in 2018, Mangiameli underwent chemotherapy and radiotherapy, achieving remission after five years. While she doesn’t currently need Imdelltra, she believes it offers hope and additional options for others with the same disease.
Despite these achievements, Amgen recognizes the need for further progress. The FDA’s approval is conditional upon the company conducting additional trials. Amgen is conducting a series of studies to test Imdelltra as both second-line and first-line therapy for advanced SCLC. These studies aim to further confirm and expand the observed optimistic results.

Amgen’s chief scientific officer, Dr. Jay Bradner, emphasized the importance of finding new treatments for SCLC, as the current options are insufficient. He expressed confidence in Imdelltra’s later-stage trials, which he believes will provide a basis for it to become the first line of treatment, offering better outcomes for patients diagnosed at an earlier stage.

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