FDA: Durvalumab Granted Breakthrough Therapy Designation for NSCLC
The FDA decision was based on data analysis from 4 clinical trials.
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to durvalumab for patients with locally advanced, unresectable non–small cell lung cancer (NSCLC) who do not relapse after platinum-based chemoradiation.1
Durvalumab is a PD-L1 inhibitor being evaluated in several trials for potential use in NSCLC, small-cell lung cancer (SCLC), metastatic urothelial cancer (mUC), and in head and neck squamous cell carcinoma (HNSCC).
The FDA's designation was based on data from an interim analysis of the phase 3 PACIFIC trial (Clinicaltrials.gov Identifier: NCT02125461), for which researchers enrolled 713 patients who had responded to platinum-based chemoradiotherapy. Patients were randomly assigned to receive durvalumab or placebo; the analysis showed a significant improvement in progression-free survival among patients in this setting.2
Durvalumab is also being tested as adjuvant therapy in NSCLC in the phase 3 ADJUVANT trial, and as monotherapy and in combination with tremelimumab for advanced NSCLC in the phase 3 MYSTIC (ClinicalTrials.gov Identifier: NCT02453282), NEPTUNE (ClinicalTrials.gov Identifier: NCT02542293), and PEARL studies.
Durvalumab is also being evaluated with and without tremelimumab in combination with chemotherapy in the POSEIDON trial (ClinicalTrials.gov Identifier: NCT03164616).
The FDA grants breakthrough therapy designation to medications that treat a serious disease and show early evidence of clinical benefit. Treatment must also demonstrate improvement on clinically significant endpoints over current therapies, and must address significant unmet medical needs.
- Imfinzi granted breakthrough therapy designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer [news release]. Gaithersburg, MD: AstraZeneca; July 31, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/imfinzi-granted-breakthrough-therapy-designation-by-us-fda-for-patients-with-locally-advanced-unresectable-non-small-cell-lung-cancer-31072017.html. Accessed July 31, 2017.
- Imfinzi significantly reduces the risk of disease worsening or death in the Phase III PACIFIC trial for Stage III unresectable lung cancer [news release]. Gaithersburg, MD: AstraZeneca; May 12, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/imfinzi-significantly-reduces-the-risk-of-disease-worsening-or-death-in-the-phase-iii-pacific-trial-for-stage-iii-unresectable-lung-cancer-12052017.html. Accessed July 31, 2017.