FDA approves shorter monitoring period for first two doses of Amgen’s Imdelltra

The U.S. Food and Drug Administration has approved an update to the prescribing information for Amgen’s Imdelltra, also known as tarlatamab, substantially reducing the recommended monitoring period following the first two doses of treatment.

Under the updated requirements, patients receiving Imdelltra should be monitored in an appropriate healthcare setting for 6 to 8 hours from the beginning of each of their first two infusions. The previous recommendation required monitoring for 22 to 24 hours.

Patients will also undergo a follow up assessment, including checks of vital signs, on the day after each of the first two doses.

Amgen said the change could significantly reduce the amount of time people with extensive stage small cell lung cancer spend in healthcare settings during the initial treatment period. It could also make administering Imdelltra less complex for community oncology practices, where an estimated 80% to 85% of cancer patients in the U.S. receive care.

Jay Bradner, MD, Executive Vice President of Research and Development, Artificial Intelligence and Data at Amgen, said patients with small cell lung cancer are already managing an aggressive disease and that lengthy treatment and monitoring requirements can create an additional burden for both patients and healthcare providers.

He said reducing the initial monitoring period to 6 to 8 hours could help remove practical barriers to Imdelltra administration and potentially allow more patients to receive treatment closer to home. Amgen will continue working with healthcare providers to support appropriate education around the use of the therapy.

David M. Waterhouse, MD, MPH, FASCO, a medical oncologist and hematologist at Oncology Hematology Care in Cincinnati, said shorter monitoring could make Imdelltra easier to administer within community oncology practices. He noted that patients with small cell lung cancer can be seriously unwell, making lengthy journeys and extended stays in healthcare settings particularly difficult for patients and their families.

Extensive stage small cell lung cancer is an aggressive form of lung cancer, and most patients experience disease progression after receiving first line treatment.

The FDA label change applies specifically to the first two doses of Imdelltra. Other monitoring and supportive care recommendations remain unchanged.

Patients should continue to be monitored for 6 to 8 hours after their third dose on Cycle 1 Day 15 and during Cycle 2. Monitoring then decreases to 3 to 4 hours during Cycles 3 and 4 and to 2 hours from Cycle 5 onwards.

Following the Cycle 1 Day 1 and Cycle 1 Day 8 doses, patients are also advised to remain within one hour of an appropriate healthcare setting for a total of 48 hours from the beginning of the Imdelltra infusion and to be accompanied by a caregiver.

Follow up assessments, including vital sign checks, are recommended on Cycle 1 Days 2 and 9 after the first and second doses respectively.

The regulatory update follows Amgen’s recent announcement of positive topline overall survival findings from the Phase III DeLLphi 305 trial evaluating Imdelltra in first line extensive stage small cell lung cancer.

Amgen is also assessing shorter monitoring periods in several ongoing clinical studies across different indications and stages of treatment. The company said these studies could help determine whether monitoring requirements can be reduced further in the future.

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Amgen, cancer treatment, community oncology, FDA, FDA Approval, imdelltra, lung cancer, Oncology, pharma news