Enhertu's expanded Breast Cancer approval - good news for Avacta?10 Mar 2026 13:25
i assume if we are going to benchmark ourselves against enhertu - any current success/progress for them is potential future success/progress for us?
daiichi sankyo and astrazeneca’s reigning antibody-drug conjugate (adc) enhertu is homing in on another potential approval, with the fda this week granting the drug priority review in a subset of her2-positive breast cancer patients. daiichi and az are specifically pursuing a green light in patients with residual invasive disease after neoadjuvant treatment with a her2-targeted drug.
the fda priority review tag follows receipt of a breakthrough therapy designation in the indication in december and tees up enhertu for a regulatory decision by july 7, daiichi and az said in a march 9 press release.
the partners’ application leans on results from the late-stage destiny-breast05 study, in which enhertu curbed the risk of invasive disease recurrence or death by 53% versus a control of trastuzumab emtansine (roche’s kadcyla) in the specific breast cancer patient population.
enhertu also reduced the risk of distant disease recurrence and brain metastases by 51% and 36%, respectively, compared to the trial’s kadcyla control.
“for patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease,” ken take****a, m.d., daiichi’s global head of r&d, said in a statement.
the u.s. filing comes as submissions based on destiny-breast05 are already under review in the european union and japan, az and daiichi said. and ahead of the new july decision date set by the fda, the partners are also awaiting the u.s. regulator’s verdict on their enhertu application for neoadjuvant treatment in her2-positive stage 2 or 3 breast cancer.
since its initial 2019 nod in her2-positive unresectable or metastatic breast cancer patients who’ve received two or more anti-her2 regimens, enhertu has gone on to pick a suite of breast cancer indications, and the drug late last year scored a coveted first-line nod in combination with roche’s perjeta.