AstraZeneca received two positive opinions from the EU's Committee for Medicinal Products for Human Use (CHMP) on July 24, 2026, covering new indications for its cancer therapy Enhertu and respiratory treatment Trixeo Aerosphere .
The CHMP recommended Enhertu, developed with Daiichi Sankyo, in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The opinion is based on the Phase III DESTINY-Breast09 trial, which showed the combination cut the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab regimen, with median progression-free survival of 40.7 months versus 26.9 months. If approved, it would be the first new EU treatment in over a decade for this patient population, according to AstraZeneca and Daiichi Sankyo executives Susan Galbraith and John Tsai .
Separately, the CHMP recommended Trixeo Aerosphere for maintenance treatment of asthma in patients 12 and older whose disease isn't controlled on medium-dose inhaled corticosteroid/LABA therapy. The recommendation draws on the KALOS and LOGOS Phase III trials, involving roughly 4,300 patients, which showed statistically significant lung function gains and reduced exacerbation rates versus dual therapy, with no new safety signals. Approval would give Trixeo, already cleared for asthma in the US, a second EU indication beyond COPD, said AstraZeneca's Ruud Dobber .
Both opinions now await final European Commission decisions.
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