FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC

Approval:
The FDA has approved AstraZeneca's Imfinzi (durvalumab) for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based chemotherapy and radiation therapy14.

Clinical Trial:
The approval is based on the ADRIATIC Phase III trial, which showed that Imfinzi reduced the risk of death by 27% and achieved a median overall survival (OS) of 55.9 months versus 33.4 months with placebo14.

Significance:
This marks the first systemic immunotherapy available for LS-SCLC, representing a significant advancement in treatment options for this aggressive form of lung cancer1.

Breakthrough Therapy Designation and Priority Review:
Imfinzi received Breakthrough Therapy Designation and Priority Review from the FDA for this indication, highlighting its potential to significantly improve outcomes for patients with LS-SCLC34.

Impact:
The approval is seen as a game changer for patients with LS-SCLC, offering a new treatment option that holds the potential to significantly improve survival rates and outcomes12.

Sources:

1. https://www.pharmexec.com/view/fda-approves-astrazeneca-imfinzi-limited-stage-small-cell-lung-cancer

2. https://www.biospace.com/fda/astrazenecas-imfinzi-scores-lung-cancer-wins-with-fdas-nsclc-approval-sclc-priority-review

3. https://www.onclive.com/view/fda-grants-priority-review-to-durvalumab-for-ls-sclc-after-concurrent-chemoradiotherapy

4. https://www.onclive.com/view/fda-approves-durvalumab-for-limited-stage-small-cell-lung-cancer