The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung cancer (NSCLC) with an activating HER2 mutation.
Phase II Trial Results Support CHMP’s Recommendation
The recommendation from the CHMP is supported by the results of a Phase II trial, which demonstrated that Enhertu achieved confirmed objective response (ORR) and disease control (DCR) rates of 49.0% and 93.1%, respectively. The trial’s findings indicate that the treatment is effective in targeting advanced NSCLC with HER2 mutations. Additionally, the study observed no new safety signals, further validating the safety profile of Enhertu.
Implications for Lung Cancer Treatment
This positive opinion from the CHMP is a significant step towards potentially expanding the treatment options for patients with advanced NSCLC harboring HER2 mutations. Enhertu’s potential approval would provide an additional therapeutic option for this patient population, offering a targeted approach to managing a difficult-to-treat form of lung cancer.-Fineline Info & Tech
