The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision follows positive results from a Phase II trial that demonstrated the drug’s antitumor activity, leading to durable responses and promising survival outcomes.
The FDA’s priority review designation is reserved for treatments that show significant improvements over existing options or fulfill unmet clinical needs. Tarlatamab received this designation after being granted breakthrough therapy status earlier in the year.
Amgen’s therapy is not only in a late-stage study for the submitted indication but is also being explored in earlier stages of SCLC, neuroendocrine prostate cancer, and in combination with an anti-PD-1 therapy.- Flcube.com
