The U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to Amgen’s (NASDAQ:) new drug tarlatamab, sold under the brand name Imdelltra, to treat adults with advanced small cell lung cancer. The approval is specifically for cases that have progressed after chemotherapy.
Imdelltra is a bispecific antibody therapy that works by pairing a cancer cell with an immune cell, allowing the immune system to target and destroy the cancer. This approach is based on Amgen’s extensive research into bispecific antibodies.
The effectiveness of Imdelltra was demonstrated in a mid-stage study, which showed a reduction in tumor size in 40% of patients receiving a 10 mg dose of tarlatamab via intravenous infusion every two weeks.
“While tarlatamab/Imdelltra is not yet included in our model, we note that consensus sellers are estimating a peak of $1.3 billion,” Truist Securities analysts wrote in a note.
“We see blockbuster potential for Imdelltra if it can move into earlier lines of therapy, for which Amgen has several ongoing studies,” they added.
Amgen has set the U.S. price for Imdelltra at $31,500 for the initial treatment cycle, with subsequent infusions costing $30,000 each. The annual cost of treatment is estimated at $781,500.
Patients treated with Imdelltra in the study had a median survival of 14.3 months, a marked improvement over the typical survival of about five months for advanced small cell lung cancer.
However, the treatment has potential side effects, the most common of which is cytokine release syndrome. This is a condition in which the immune system overreacts to an infection or to the drug itself, which can be dangerous.
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Full FDA approval of Imdelltra is contingent on the completion of a larger, pivotal study in advanced small cell lung cancer.
Meanwhile, Amgen is also studying the drug’s effectiveness in treating patients in earlier stages of the disease.
Goldman Sachs analysts also commented on this development, saying Imdelltra’s capabilities are “undervalued by investors.”
The Wall Street firm projects global sales to peak at $3.8 billion in 2035, assuming eventual first-line approval where a Phase 1b combination study is currently underway.
“Overall, we are positive on this update and remain very constructive on AMGN as the company continues to work on key value catalysts,” they added.
AMGN shares fell more than 1% on Friday.