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Amgen Cancer Drug Wins FDA Nod

The U.S. Food and Drug Administration on Thursday approved Amgen’s (NASDAQ:AMGN) therapy for patients with the most deadly form of lung cancer.

The agency cleared the drug, which will be marketed under the name Imdelltra, as a second or later line of treatment for people with advanced small-cell lung cancer. That means patients can take the drug if their cancer progresses while on or after trying one other form of treatment, which is typically a type of chemotherapy. Amgen’s drug is also known by its generic name tarlatamab.

In clinical trials, Amgen’s drug has been shown to reduce tumor growth and help people with small-cell lung cancer live significantly longer.

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 said. Around 80% to 85% of people with small-cell lung cancer are diagnosed with an advanced stage of the disease, according to a study published in the Journal of Cancer.

There are around 35,000 patients with small-cell lung cancer in the U.S., according to experts.

Small-cell lung cancer usually starts in the airways of the lung and grows rapidly, creating large tumors and spreading throughout the body. Symptoms include bloody phlegm, cough, chest pain and shortness of breath.

Only 3% of patients with small-cell lung cancer that has spread to other parts of the body live past 5 years, according to the American Cancer Society.

AMGN shares declined $3.72, or 1.2%, to $311.00.