The US Food and Drug Administration (FDA) has approved Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) for two new indications in human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

Data from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials support these approvals.

They cover the use of Enhertu in both the neoadjuvant and adjuvant treatment settings for adult patients.

In the neoadjuvant setting, the therapy, followed by a regimen of taxane, trastuzumab, and pertuzumab (THP), is now approved for adults with HER2-positive stage 2 or stage 3 breast cancer.

For the adjuvant setting, the approval applies to adults with HER2-positive breast cancer with residual invasive disease after prior treatment with trastuzumab (with or without pertuzumab) and a taxane-based regimen.

Daiichi Sankyo oncology business global head and president and CEO Ken Keller said: “Enhertu has redefined the treatment of HER2-expressing breast cancer with practice-changing data across six breast cancer indications in seven years.

“Enhertu is now approved in the US across both early and metastatic HER2-positive breast cancer, accomplishing what we set out to achieve a little over a decade ago for patients at the start of our comprehensive clinical development programme.”

DESTINY-Breast11 showed that Enhertu, followed by THP, yielded a pathologic complete response rate of 67.3% versus 56.3% for dose-dense doxorubicin and cyclophosphamide plus THP, an improvement of 11.2%.

DESTINY-Breast05 found that Enhertu reduced the risk of invasive disease recurrence or death by 53% versus trastuzumab emtansine.

DESTINY-Breast05 data supported the inclusion of Enhertu in the NCCN Clinical Practice Guidelines in Oncology as a Category 1 recommended treatment. No new safety concerns were identified in the trials.

The FDA reviewed both regulatory submissions under Project Orbis. Additional regulatory reviews are ongoing in other countries. Enhertu is already approved in more than 95 countries for metastatic HER2-positive breast cancer.

Following these approvals, a $155m payment is due from AstraZeneca to Daiichi Sankyo.

Earlier this year, Daiichi Sankyo and AstraZeneca’s Enhertu received approval from China’s National Medical Products Administration (NMPA) for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.