FDA grants accelerated approval to Tarlatumab-dlle for extensive stage small cell lung cancer

The Food and Drug Administration recently granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. This decision was made based on the results of the DeLLphi-301 study, which demonstrated a 40% overall response rate (ORR) and a median duration of response (DOR) of 9.7 months.

The most common adverse reactions were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation. The most common Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.

The accelerated approval was granted under Project Orbis, a collaboration initiative between the FDA and international health regulatory agencies in Brazil, Canada, Israel, and the United Kingdom. This review used the Real-Time Oncology Review pilot program and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA's assessment. The application review is still ongoing in other regulatory agencies as part of Project Orbis.

Healthcare professionals are advised to report all serious adverse events suspected to be associated with the use of any medicine and device to the MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE's Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

This news is brought to you by the FDA Center for Drug Evaluation and Research's Office of Communication and Educational Resources. You can read the full press release from the FDA here.