One Fast-Growing Amgen Drug Still Has Something To Prove
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Amgen (AMGN) sells IMDELLTRA as a second-line treatment for small cell lung cancer, and management believes that with additional regulatory approvals it can become a cornerstone therapy across multiple stages of the disease. Wider use also means more community cancer clinics starting patients on the drug. That wider role is not settled yet, and IMDELLTRA sits in a part of Amgen that is growing faster than the company as a whole.
IMDELLTRA Is Growing Fast In Amgen’s Cancer Business
IMDELLTRA sales more than doubled from a year earlier to $406 million in the third quarter of 2026. Amgen now wants to extend the drug from second-line use to frontline maintenance treatment, after its 305 study tested it in that setting. During Amgen’s November 3 call for that quarter, 4 of the 12 analyst questions touched on the launch and uptake of new drugs. These questions came from 4 different analysts, and IMDELLTRA’s ramp came up in one of them.
IMDELLTRA belongs to Amgen’s Innovative Oncology portfolio, which brought in $2.1 billion in the quarter. This portfolio accounted for about a fifth of the company’s $10.4 billion in total revenues and grew 21% from a year earlier, compared with an 8.5% increase for Amgen’s total revenue. While IMDELLTRA remains small relative to Amgen as a whole, it is expanding faster than the surrounding portfolio, which itself is growing well ahead of the broader company.
Amgen Points To Shorter Monitoring For IMDELLTRA
Amgen’s case for wider use rests on the drug’s trial results and on shorter monitoring. In its DeLLphi-304 trial, patients on IMDELLTRA had a 40% lower risk of death than those on chemotherapy in second-line treatment. A practical hurdle is how long patients must be watched after a dose, and management has said the FDA shortened the recommended monitoring period for the first two doses from 22-24 hours to 6-8 hours.
That change is already helping community oncology clinics start second-line patients on IMDELLTRA, management said. In the 305 study, monitoring went down to 1 to 2 hours, and management hopes for a further improvement in the label if the drug is extended to frontline maintenance. Amgen is also moving with urgency on talks with health authorities and guideline groups, so that the new trial results can reach clinical practice quickly. When another analyst asked how large the frontline maintenance opportunity could be, management said Amgen does not issue product-specific guidance, so it has put no sales figure on what wider use could be worth.
Amgen Needs A Frontline Approval For IMDELLTRA
Management has tied IMDELLTRA’s wider role to additional regulatory approvals, and an approval for frontline maintenance use is one of them. Amgen said it is now working to file quickly with regulators around the world. Until they decide, IMDELLTRA’s quarterly sales are the measure to watch in Amgen’s next report, expected in February 2027.
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