Amgen's IMDYLLTRA® Receives Conditional UK Approval for Small Cell Lung Cancer
The UK's MHRA has granted conditional marketing authorisation for Amgen's IMDYLLTRA® (tarlatamaab) for the treatment of extensive-stage small cell lung cancer.
Amgen has received a conditional marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its drug IMDYLLTRA® (tarlatamaab). The authorisation permits the use of the drug in adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after at least two prior lines of therapy, including platinum-based chemotherapy.
Small cell lung cancer (SCLC) is an aggressive subtype, accounting for approximately 15% of lung cancer diagnoses in the UK. ES-SCLC is characterised by rapid tumour growth and metastasis, often leading to late-stage diagnosis due to the absence of early symptoms.
The conditional approval is based on data from the Phase 2 DeLLphi-301 study. In the trial, tarlatamaab demonstrated a 41% objective response rate (ORR) and a median duration of response (DoR) of 9.7 months in patients with ES-SCLC who had progressed on two or more prior treatment regimens.
IMDYLLTRA® functions as a bispecific T-cell engager, targeting DLL3 on tumour cells and CD3 on T-cells to activate the immune system against cancer. Reported common side effects include cytokine release syndrome and pyrexia.