India, March 17 -- British drug major AstraZeneca Plc (AZN,AZN.L) announced Monday that its Imfinzi (durvalumab) has been approved in the European Union as first and only immunotherapy for limited-stage small cell lung cancer or LS-SCLC.
The approval is to treat adults with LS-SCLC whose disease has not progressed following platinum-based chemoradiation therapy or CRT.
The European Commission's approval follows the positive opinion of the Committee for Medicinal Products for Human Use, based on results from the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death versus placebo.
SCLC, a highly aggressive form of lung cancer, typically recurs and progresses rapidly, despite initial response to standard-of-care chemo...