AstraZeneca Plc (NASDAQ: AZN) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Etcamah in combination with a CDK4/6 inhibitor. The approval covers adult patients with hormone receptor-positive, HER2-negative metastatic breast cancer that has an ESR1 mutation.
The authorization is based on data from the pivotal SERENA-6 Phase 3 trial. The study evaluated the combination therapy against standard treatments. The results indicated that the Etcamah combination reduced the risk of disease progression or death by 56% compared to standard care. Patients receiving the therapy achieved a median progression-free survival of 16.0 months, which was an improvement over the 9.2 months observed with standard treatments.
In addition to the breast cancer approval, the company reported interim results from its DeLLphi-305 Phase 3 trial for lung cancer. The trial evaluated extensive-stage small cell lung cancer patients who remained stable after standard induction therapy. The data showed that combining Imfinzi with Amgen Inc.’s (NASDAQ: AMGN) Imdelltra as a first-line maintenance treatment improved overall survival compared to Imfinzi alone.
AstraZeneca also released full results from its OBERON and TITANIA Phase 3 trials evaluating tozorakimab for chronic obstructive pulmonary disease (COPD). The trials demonstrated that tozorakimab reduced moderate and severe exacerbations in the overall population by 30% and 29%, respectively, compared to a placebo. The FDA accepted a Biologics License Application for tozorakimab with Priority Review, setting an anticipated action date in the first quarter of 2027.
