US FDA approves Amgen drug for small cell lung cancer
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[May 17, 2024]
(Reuters) -The U.S. Food and Drug Administration on Thursday
granted accelerated approval to Amgen's tarlatamab, a targeted
immunotherapy for adults in the advanced stages of hard-to-treat small
cell lung cancer that has worsened despite chemotherapy.
The drug, marketed under the name Imdelltra, is part of Amgen's pipeline
of bispecific antibodies designed to attach to a cancer cell and an
immune cell, bringing them together so that the body's immune system can
kill the cancer.
Results from a mid-stage trial published last year in the New England
Journal of Medicine showed that tumors shrank in 40% of patients
receiving 10 mg of tarlatamab by intravenous infusion every two weeks.
Amgen said the U.S. price for Imdelltra is $31,500 for the first cycle,
and $30,000 for additional infusions. For a year of treatment, the price
would come to $781,500.
Patients in the study lived for a median of 14.3 months, compared with a
typical survival rate of about five months.
Most lung cancer cases are non-small cell, while up to 15%, according to
the American Cancer Society, are the more aggressive small cell variety
targeted by Imdelltra.
The disease, which is diagnosed in about 35,000 U.S. patients annually,
is "one of most rapidly proliferating and most aggressive cancers there
is," Jay Bradner, Amgen's chief scientific officer, said in an interview
ahead of the decision.
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An Amgen sign is seen at the company's headquarters in Thousand
Oaks, California, U.S., November 6, 2019. REUTERS/Deena Beasley/File
Photo
In clinical trials, the most common
side effect of the treatment was cytokine release syndrome, a
potentially dangerous condition that occurs when the body's immune
system responds over aggressively to infection or immunotherapy
drugs.
Amgen said it will need to complete its larger, pivotal trial in
advanced small cell lung cancer to receive full FDA approval of the
drug.
The company is also testing tarlatamab for treating patients with
earlier-stage small cell lung cancer.
If those studies prove successful, Wall Street analysts have said
tarlatamab could represent an annual sales opportunity for the
company of more than $2 billion.
Shares of Amgen, which fell by less than 1% to close at $314.72 on
Nasdaq, were unchanged after hours.
(Reporting By Deena Beasley and Sneha S K; Editing by Bill Berkrot,
Shailesh Kuber and Jamie Freed)
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