Amgen Gains on Full FDA Approval for Lung Cancer Drug Imdelltra
Pivotal data shows the first-in-class therapy reduced the risk of death by 40%, cementing its role in treating an aggressive form of lung cancer.
Amgen Inc. (NASDAQ: AMGN) saw its shares gain ground after the U.S. Food and Drug Administration (FDA) granted full approval for Imdelltra (tarlatamab), a treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed despite platinum-based chemotherapy.
The decision, announced late Tuesday, converts Imdelltra's earlier accelerated approval into a full one, backed by compelling Phase 3 clinical trial data. In pre-market trading Wednesday, Amgen shares were trading near their 52-week high, reflecting investor confidence in the drug's blockbuster potential. The stock was last seen trading around $337, within sight of its peak of $345.84.
The approval is a significant milestone for Amgen's oncology franchise and offers a new standard of care for a notoriously difficult-to-treat cancer. According to the company's announcement, the confirmatory DeLLphi-304 study demonstrated that Imdelltra reduced the risk of death by a remarkable 40% compared to standard-of-care chemotherapy.
Patients treated with Imdelltra achieved a median overall survival of 13.6 months, a clinically meaningful improvement over the 8.3 months observed in the chemotherapy arm. Small cell lung cancer is one of the most aggressive solid tumors, and for decades, patients who relapse have had limited options and poor prognoses.
"The full approval of Imdelltra validates its potential as a first-in-class therapy that offers a significant survival advantage for patients with extensive-stage small cell lung cancer," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "This milestone underscores our commitment to transforming care for patients with challenging cancers."
Imdelltra is a bispecific T-cell engager (BiTE) therapy, an innovative class of immunotherapies that works by redirecting the body's own T-cells to recognize and kill cancer cells. It specifically targets the DLL3 protein, which is highly expressed in SCLC tumors but minimally in healthy tissue, allowing for a targeted attack.
Wall Street analysts have been closely watching Imdelltra's development, with peak annual sales estimates ranging from $1 billion to over $3 billion. The full approval solidifies its commercial trajectory and secures its position as a key growth driver for the $185 billion biopharmaceutical giant. Analysts at firms like Truist Securities and Goldman Sachs have highlighted the drug's strong clinical profile as a key differentiator in a crowded oncology market.
The competitive landscape for lung cancer treatments remains intense. The same day as Amgen's announcement, the FDA also granted accelerated approval to a rival therapy from Bayer, underscoring the rapid pace of innovation in the field. However, Imdelltra's robust survival data in a second-line setting and its unique mechanism of action position it strongly.
Amgen's commercial strategy will now focus on expanding physician adoption and ensuring patient access. The treatment is already recommended as the sole Category 1 preferred option by the National Comprehensive Cancer Network (NCCN) for this patient population. With this full approval, Amgen can now market the drug more broadly, backed by definitive survival data that physicians and payers value highly.
The approval marks a critical success for Amgen's R&D engine and reinforces its leadership in both oncology and BiTE technology. For patients and investors alike, Imdelltra represents a significant breakthrough with the potential to reshape the treatment paradigm for a devastating disease.