Amgen has announced that the US Food and Drug Administration (FDA) recently approved an update to the Imdelltra (tarlatamab-dlle) prescribing information that substantially reduces the recommended monitoring time for the first 2 doses of treatment in an appropriate healthcare setting.

This approval means that patients receiving Imdelltra should now be monitored for 6 to 8 hours from the start of their first 2 infusions, compared with the previously recommended 22 to 24 hours. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses.

For people living with Extensive-Stage Small Cell Lung Cancer (ES-SCLC), the change could mean substantially less time spent in a healthcare setting during the initial treatment period. The updated requirement may also reduce treatment complexity for community oncology practices, where an estimated 80 percent to 85 percent of US cancer patients receive care.

Jay Bradner, MD, Executive Vice President, Research and Development—Artificial Intelligence and Data, Amgen, said, "People being treated for Small Cell Lung Cancer are already navigating an aggressive and difficult-to-treat disease, and the time required to receive and monitor treatment can add to that burden for both patients and care centers. This approval is an important step in simplifying care for people living with and treating ES-SCLC. Reducing monitoring to 6-8 hours for the initial doses may help address practical barriers associated with administering Imdelltra and enable more patients to receive care closer to home. We continue to work closely with the healthcare community to ensure appropriate educational support for navigating Imdelltra treatment is available to providers, patients and care partners."

ES-SCLC is an aggressive form of lung cancer in which most patients experience disease progression following first-line treatment. The scope of the label update was limited to the first 2 doses, which now recommends only 6 to 8 hours of monitoring from the start of infusion in an appropriate healthcare setting.

Beyond the update to the first 2 doses and the addition of a patient assessment following those initial doses, the monitoring and supportive care recommendations remain unchanged: 6-8 hours of monitoring following the third dose (Cycle 1 Day 15) and throughout Cycle 2, decreasing to 3-4 hours for Cycles 3-4 and 2 hours for Cycle 5 and subsequent doses.

It is recommended that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with Imdelltra following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.

Patients will also receive a follow-up assessment, including vital signs, the day after each of these first 2 doses on Cycle 1, Days 2 and 9.

David M Waterhouse, MD, MPH, FASCO, Medical Oncologist/Hematologist—Oncology, Hematology Care, Cincinnati, OH, said, "In community oncology, we care for patients where they live, and for people living with Small Cell Lung Cancer, that matters. These patients are often very sick, and traveling long distances or spending extended time in a healthcare setting can be difficult for them and their families. Reducing the required monitoring period may make Imdelltra more feasible to administer in community practices, helping more patients receive treatment in their local care network and spend less time away from their support systems."

The updated monitoring requirements represent an important evolution in the administration of Imdelltra and reinforce Amgen's commitment to advancing treatments while addressing the real-world needs of people living with cancer.

Amgen recently announced landmark positive topline Overall Survival (OS) data from the phase 3 DeLLphi-305 study in first-line ES-SCLC. Reduced post-infusion monitoring timing is being evaluated in several ongoing studies across indications and lines of therapy which will continue to inform the potential to further reduce monitoring approaches in the future.