FDA Approves Imdelltra To Treat a Deadly Form of Lung Cancer

The FDA has signed off on the use of Imdelltra to treat a deadly form of lung cancer known as small-cell lung cancer.

CNBC confirmed that the drug, which is manufactured by Amgen and known by its generic name tarlatamab, can be taken alongside other drugs or as a standalone treatment.

Clinical studies have proven that Imdelltra reduces tumor growth and increases life expectancy amongst patients who take it, versus those who do not.

“Of the more than 2.2 million patients who are diagnosed with lung cancer worldwide each year, small-cell lung cancer comprises 15%, or 330,000, of those cases,” Amgen reported to CNBC. According to research published in the Journal of Cancer, approximately 80% to 85% of individuals diagnosed with small-cell lung cancer are found to be in an advanced stage of the disease.

Per the National Cancer Institute, small-cell lung cancer starts in the lung airways and spreads rapidly, causing tumors everywhere it spreads. If left untreated, small-cell lung cancer can claim a patient’s life within two to four months. Only 3% of patients diagnosed with the disease live past five years after the diagnosis.

Despite this promising development, many cancer drugs are still unproven in their efficacy more than five years after their accelerated availability.

According to research in the Journal of the American Medical Association, 46 cancer medications received expedited approval between 2013 and 2017. Sixty-three percent of them changed to regular approval. In trials, just 43% showed a therapeutic effect, though. Thus, this study concluded that while expedited approval may be beneficial, many cancer medications do not show promise in prolonging patient lives or enhancing their quality of life.

According to the FDA, pharmaceutical companies still need to carry out studies to validate the expected clinical advantages. The FDA gives final approval if the confirmatory trial demonstrates that the medication has a therapeutic benefit.

Cancer specialist and bioethicist at the University of Pennsylvania, Dr. Ezekiel Emanuel, who was not involved in JAMA’s clinical research, stated, “Five years after the initial accelerated approval, you should have a definitive answer. Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work.”