International Intel: a Glance at the Top Global Breast Cancer News From January-March 2026

In In The News by Barbara Jacoby

By: Ashling Wahner

From: onclive.com

Key Takeaways

  • China’s NMPA conditionally approved neoadjuvant T-DXd→THP in stage II/III HER2-positive breast cancer, improving pCR to 67.29% versus 56.25% with dose-dense AC→THP.
  • NMPA authorized sacituzumab tirumotecan for unresectable/metastatic HR+/HER2− disease after endocrine therapy and ≥1 chemotherapy line, with median PFS 8.3 versus 4.1 months.
  • EMA validated a Type II variation for first-line T-DXd plus pertuzumab in unresectable/metastatic HER2-positive disease, with DESTINY-Breast09 median PFS 40.7 versus 26.9 months versus THP.
  • Post-neoadjuvant T-DXd monotherapy filing in the EU targets residual invasive HER2-positive disease after neoadjuvant HER2 therapy, showing HR 0.47 versus T-DM1 in DESTINY-Breast05.
  • Japan accepted an sNDA for datopotamab deruxtecan in recurrent/unresectable TNBC ineligible for immunotherapy, supported by OS HR 0.79 and PFS HR 0.57 versus chemotherapy.

The start of 2026 coincided with regulatory updates heard around the world regarding therapies for HER2-positive breast cancer, triple-negative breast cancer (TNBC), and more. Read on for a recap!

And, see our FDA breast cancer recap from March 2026 for more regulatory buzz happening around breast cancer treatments in the US!

Is neoadjuvant fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) followed by paclitaxel, trastuzumab (Herceptin), and pertuzumab (Perjeta; THP) approved in China for HER2-positive breast cancer?

On March 27, 2026, China’s National Medical Products Administration (NMPA) granted conditional approval to neoadjuvant T-DXD followed by THP for the treatment of adult patients with stage II or III HER2-positive breast cancer.1 Data from the phase 3 DESTINY-Breast11 trial (NCT05113251) supported this decision. In the trial, patients treated with T-DXd followed by THP (n = 321) had a statistically significant and clinically meaningful improvement in pathologic complete response rate vs those treated with standard dose-dense doxorubicin and cyclophosphamide followed by THP (n = 320), at 67.29% vs 56.25%, respectively.1,2

Notably, the FDA is reviewing a supplemental biologics license application seeking the approval of neoadjuvant T-DXd followed by THP for the treatment of adult patients with high-risk, HER2-positive, stage II/III breast cancer, with a Prescription Drug User Fee Act (PDUFA) target action date of May 18, 2026.3

Is sacituzumab tirumotecan (sac-TMT; SKB264/MK-2870) approved in China for hormone receptor–positive, HER2-negative breast cancer?

On February 6, 2026, China’s NMPA approved the TROP2-directed antibody-drug conjugate sac-TMT for the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-negative breast cancer who have been previously treated with endocrine therapy and 1 or more lines of chemotherapy for advanced disease.4 This regulatory decision was backed by data from the phase 3 OptiTROP-Breast02 study (NCT06081959), in which patients who received sac-TMT (n = 200) achieved a median progression-free survival (PFS) of 8.3 months (95% CI, 7.0-8.6) vs 4.1 months (9% CI, 3.0-4.3) among those who received investigator’s choice of chemotherapy (n = 199; HR, 0.35; 95% CI, 0.26-0.48; P < .0001).4,5

What is the regulatory status of first-line T-DXd plus pertuzumab in the European Union (EU) for HER2-positive metastatic breast cancer?

On January 19, 2026, the European Medicines Agency (EMA) announced its validation of the Type II variation marketing authorization application for first-line T-DXd in combination with pertuzumab for adult patients with unresectable or metastatic HER2-positive breast cancer.6 This regulatory decision was backed by findings from the phase 3 DESTINY-Breast09 trial (NCT04784715), in which patients treated with the investigational combination (n = 383) had a median PFS of 40.7 months (95% CI, 36.5-not calculable [NC]) vs 26.9 months (95% CI, 21.8-NC) with THP (n = 387; HR, 0.56; 95% CI, 0.44-0.71; P < .00001).6,7

Notably, on December 15, 2025, the FDA approved T-DXd plus pertuzumab for use in the first-line setting for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by an FDA-approved test.8

What is the regulatory status of post-neoadjuvant T-DXd in the EU for HER2-positive early breast cancer?

On February 19, 2026, the EMA announced its validation of the Type II variation marketing authorization application seeking the approval of T-DXd monotherapy for the treatment of adult patients with HER2-positive breast cancer and residual invasive disease following neoadjuvant HER2-directed therapy.9 This decision was supported by data from the phase 3 DESTINY-Breast05 trial (NCT04622319), in which patients who received post-neoadjuvant T-DXd (n = 818) achieved a 53% reduction in the risk of disease progression or death vs those who received ado-trastuzumab emtansine (Kadcyla; n = 817; HR, 0.47; 95% CI, 0.34-0.66; P < .0001).9,10

Post-neoadjuvant T-DXd for this indication is also under FDA priority review, with a PDUFA target action date of July 7, 2026.11

What does the future look like for datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) use in Japan for immunotherapy-ineligible patients with metastatic TNBC?

In February 2026, a supplemental new drug application (sNDA) was submitted to Japan’s Ministry of Health, Labour and Welfare seeking the approval of Dato-DXd for the treatment of adult patients with recurrent or unresectable TNBC.12 This sNDA was supported by data from the phase 3 TROPION-Breast02 trial (NCT05374512), which showed that patients who received Dato-DXd (n = 323) achieved a 21% reduction in the risk of death (HR, 0.79; 95% CI, 0.64-0.98; P = .0291) and a 43% reduction in the risk of disease progression or death (HR, 0.57; 95% CI, 0.47-0.69; P < .0001) vs those who received investigator’s choice of chemotherapy (n = 321).12,13

Notably, Dato-DXd is also under FDA priority review for this indication, with a PDUFA target action date in the second quarter of 2026.14

References

  1. Enhertu followed by THP approved in China as the first and only HER2 directed ADC for the neoadjuvant treatment of HER2 positive breast cancer. News release. Daiichi-Sankyo. March 27, 2026. Accessed April 6, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202603/20260327_E.pdf
  2. Harbeck N, Modi S, Pusztai L, et al. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): a randomised, open-label, multicentre, phase III trial. Ann Oncol. 2026;37(2):166-179. doi:10.1016/j.annonc.2025.10.019
  3. Enhertu followed by THP supplemental biologics license application accepted in the U.S. for patients with high-risk HER2 positive early-stage breast cancer prior to surgery. News release. Daiichi Sankyo. October 1, 2025. Accessed April 6, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202510/20251001_E.pdf
  4. Kelun-Biotech announces fourth indication for sacituzumab tirumotecan (sac-TMT) approved by NMPA in HR+/HER2- breast cancer. News release. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. February 6, 2026. Accessed April 6, 2026. https://en.kelun-biotech.com/newsCenter.aspx?mid=18#18
  5. Fan Y, Li H, Wang H, et al. LBA23 Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase III OptiTROP-Breast02 study. Ann Oncol. 2025;36(suppl 2):S1568-S1569. doi:10.1016/j.annonc.2025.09.033
  6. Enhertu plus pertuzumab Type II variation application validated in the EU as first-line treatment of patients with HER2-positive metastatic breast cancer. News release. Daiichi Sankyo. January 19, 2026. Accessed April 6, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202601/20260119_E2.pdf
  7. Tolaney S, Jiang Z, Zhang Q, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): interim results from DESTINY-Breast09. J Clin Oncol. 2025;43(suppl 17):LBA1008. doi:10.1200/JCO.2025.43.17_suppl.LBA1008
  8. FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer. FDA. December 15, 2025. Accessed April 7, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive
  9. Enhertu® Type II variation application validated in the EU as post-neoadjuvant treatment for patients with HER2 positive early breast cancer. News release. Daiichi Sankyo. February 19, 2026. Accessed April 7, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260219_E.pdf
  10. Geyer CE, Park YH, Shao Z, et al. LBA1 trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): interim analysis of DESTINY-Breast05. Ann Oncol. 2025;36(suppl 2):S1556-S1557. doi:10.1016/j.annonc.2025.09.021
  11. Enhertu granted priority review in the U.S. as post-neoadjuvant treatment for patients with HER2 positive early breast cancer. News release. Daiichi Sankyo. March 9, 2026. Accessed April 6, 2026. https://www.biospace.com/press-releases/enhertu-granted-priority-review-in-the-u-s-as-post-neoadjuvant-treatment-for-patients-with-her2-positive-early-breast-cancer
  12. DATROWAY supplemental new drug application submitted in Japan for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy. News release. Daiichi Sankyo. February 12, 2026. Accessed April 6, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202602/20260212_E.pdf
  13. Dent RA, Shao Z, Schmid P, et al. First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: primary results from the randomised, phase 3 TROPION-Breast02 trial. Ann Oncol. 2025;36(suppl 2):S1566-S1567. doi:10.1016/j.annonc.2025.09.031
  14. Datroway (datopotamab deruxtecan-dlnk) granted priority review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. News release. AstraZeneca. February 3, 2026. Accessed April 6, 2026. https://www.astrazeneca-us.com/media/press-releases/2026/DATROWAY-datopotamab-deruxtecan-dlnk-granted-Priority-Review-in-the-US-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-who-are-not-candidates-for-immunotherapy.html