…….. catching up on FDA approvals
The FDA recently approved a new infused therapy, Imdelltra (tarlatamab-dlle) from Amgen, indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Imdelltra is the first bispecific delta-like ligand 3 (DLL3)-directed CD3 Tcell.
Amgen said that it has been decades of no real treatment advances for this type of lung cancer. With small cell lung cancer, the disease has typically spread beyond the lung by the time it is diagnosed and most patients live just eight to 13 months after their diagnosis, despite having chemotherapy and immunotherapy.
Imdelltra was approved with a Black Box Warning for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome.
Amgen said the U.S. price for Imdelltra is $31,500 for the first cycle, and $30,000 for subsequent cycles. The company said trial patients were on the treatment for a median of over five months, which would equate to a commercial price of about $166,500.
CLICK HERE to access prescribing information
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