FDA Cuts Monitoring Time for Amgen's IMDELLTRA Treatment
The US FDA has approved a reduction in monitoring time for patients receiving Amgen's IMDELLTRA (tarlatamab-dlle) treatment. The recommended monitoring period for the first two doses of IMDELLTRA will now be 6 to 8 hours, down from the previous 22 to 24 hours.
This change applies to adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. Patients will also undergo a follow-up assessment, including vital signs, the day after each of those initial doses.
According to Jay Bradner, executive vice president at Amgen, this approval is an important step in simplifying care for people living with and treating ES-SCLC. Reducing monitoring requirements may help address practical barriers associated with administering IMDELLTRA and enable more patients to receive care closer to home.
Community oncology practices could also benefit from the updated prescribing information, as it could simplify logistics and allow for more patients to be treated in local care networks.