The U.S. Food and Drug Administration (FDA) on Thursday granted accelerated approval to Amgen's (NASDAQ:AMGN) new drug, tarlatamab, marketed as Imdelltra, for the treatment of adults with advanced small cell lung cancer. The approval is specifically for cases that have progressed following chemotherapy treatments.
Imdelltra is a bispecific antibody therapy that works by connecting a cancer cell to an immune cell, allowing the immune system to target and destroy the cancer, an approach that comes from Amgen's extensive research into bispecific antibodies.
The effectiveness of Imdelltra was demonstrated in a mid-stage trial, where results indicated a reduction in tumor size for 40% of patients who received a 10 mg dose of tarlatamab via intravenous infusion every two weeks.
“While tarlatamab/Imdelltra is not yet in our model, we note Consensus sellside estimates of peak $1.3B,” analysts at Truist Securities said in a note.
“We see blockbuster potential for Imdelltra if it is able to move to earlier lines of therapy, for which Amgen has multiple ongoing trials,” 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 median treatment duration in the DeLLphi-301 trial was 5.5 cycles, equivalent to just over 5 months. This results in an estimated total cost of $166,500 per patient, based on the median treatment duration.
Patients treated with Imdelltra in the study experienced a median survival of 14.3 months, a marked improvement over the typical survival rate of about five months for advanced small cell lung cancer.
The treatment, however, does come with potential side effects, the most common being cytokine release syndrome. This is a condition where the immune system reacts excessively to an infection or to the drug itself, which can be dangerous.
Full FDA approval for Imdelltra is contingent upon the completion of a larger, pivotal trial in advanced small cell lung cancer.
Meanwhile, Amgen is also exploring the drug's efficacy in treating patients with earlier stages of the disease.
Analysts at Goldman Sachs also commented on the development, saying the opportunity for Imdelltra is “underappreciated by investors.”
The Wall Street firm projects peak global sales of $3.8 billion in 2035, assuming eventual approval in the first-line setting, where a Phase 1b combination study is currently enrolling.
“Overall, we view this update positively and remain highly constructive on AMGN as the company continues to execute on key value-driving catalysts,” they added.
AMGN shares fell more than 1% Friday.