Fierce Pharma May 17, 2024
Seven months after Amgen’s chief medical officer referred to trial results for the company’s investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).
The breakthrough therapy is endorsed for patients whose disease has worsened after or throughout treatment with platinum-based chemotherapy. The accelerated approval—which was delivered nearly a month before the agency’s June 12 target decision date—is contingent upon verification of clinical benefit in a confirmatory trial.
Imdelltra activates a patient’s T cells to attack Delta-like ligand 3 (DLL3)-expressing tumors. While SCLC cases comprise just 15% of lung cancers, they’re typically deadlier and more aggressive than non-small cell lung cancer.
The bispecific...
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