The FDA has approved the use of Imdelltra to treat small-cell lung cancer, a deadly form of lung cancer.
CNBC confirmed that Amgen’s drug, also known as tarlatamab, can be used in combination with other drugs or on its own.
Clinical studies have shown that Imdelltra can reduce tumor growth and improve life expectancy for patients compared to those not taking it.
“Out of the 2.2 million lung cancer patients diagnosed annually worldwide, 15% (330,000) have small-cell lung cancer,” Amgen reported to CNBC. Research published in the Journal of Cancer indicates that 80% to 85% of small-cell lung cancer cases are diagnosed at an advanced stage.
According to the National Cancer Institute, small-cell lung cancer originates in the lung airways and spreads quickly, forming tumors throughout the body. Without treatment, it can be fatal within two to four months, with only 3% of patients surviving past five years post-diagnosis.
However, despite this positive development, many cancer drugs remain unproven in their effectiveness even five years after accelerated approval.
Research published in the Journal of the American Medical Association revealed that out of 46 cancer drugs with expedited approval between 2013 and 2017, only 43% showed therapeutic efficacy in trials. Therefore, while expedited approval can be beneficial, many cancer drugs may not actually improve patient survival or quality of life.
According to the FDA, pharmaceutical companies must conduct studies to confirm the clinical benefits of their drugs. Final approval is granted based on the results of confirmatory trials demonstrating therapeutic advantages.
Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania not involved in the JAMA research, commented, “After five years of accelerated approval, there should be a clear answer on efficacy. It’s concerning if we’re still uncertain about the effectiveness of these drugs when so many people are using them.”
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