International Intel: A Glance at the Top Global Breast Cancer News From April-June 2026

Read on for a recap of the breast cancer regulatory buzz that happened around the world in recent months, including antibody-drug conjugates under review and an approval in Europe for a triple-negative breast cancer (TNBC) therapy.

Also, see our FDA breast cancer recap from June 2026 for more regulatory buzz happening around breast cancer treatments in the United States!

What is the regulatory status of trastuzumab pamirtecan in HER2-positive metastatic breast cancer in China?

On April 9, 2026, the National Medical Products Administration (NMPA) of China accepted for review a biologics license application (BLA) seeking the approval of second-line trastuzumab pamirtecan (T-Pam; DB-1303; BNT323) for adult patients with unresectable or metastatic HER2-positive breast cancer.¹

This BLA submission was supported by interim findings from the phase 3 Study DB-1303-O-3001 (NCT06265428). An independent data monitoring committee reported that the trial met its primary end point of a statistically significant progression-free survival (PFS) improvement by blinded independent central review with T-Pam vs ado-trastuzumab emtansine (Kadcyla; T-DM1).

What is the regulatory story of camizestrant-based therapy in ESR1-emergent ER-positive, HER2-negative metastatic breast cancer?

On May 23, 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of camizestrant plus a CDK4/6 inhibitor for the treatment of adult patients with estrogen receptor (ER)–positive, HER2-negative locally advanced or metastatic breast cancer upon the detection of an emergent ESR1 mutation in ctDNA prior to radiographic disease progression during first-line treatment with endocrine therapy in combination with a CDK4/6 inhibitor.²

The CHMP recommendation was backed by data from the phase 3 SERENA-6 trial (NCT04964934), which showed that switching from an aromatase inhibitor to camizestrant and continuing the same CDK4/6 inhibitor reduced the risk of disease progression or death by 56% vs continuing an aromatase inhibitor plus a CDK4/6 inhibitor.³ The median PFS was 16.0 months (95% CI, 12.7-18.2) in the camizestrant arm vs 9.2 months (95% CI, 7.2-9.5) in the control arm (HR, 0.44; 95% CI, 0.31-0.60; P < .00001). The respective 12-month PFS rates in these arms were 60.7% vs 33.4%, and the respective 24-month PFS rates were 29.7% and 5.4%.

Is sacituzumab govitecan monotherapy approved in Europe for TNBC?

On June 23, 2026, the European Commission granted marketing authorization to sacituzumab govitecan (Trodelvy) monotherapy for adult patients with unresectable or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are ineligible for treatment with PD-(L)1 inhibitors.⁴

This approval was supported by results from the phase 3 ASCENT-03 trial (NCT05382299). In the trial, patients with TNBC who were not eligible for treatment with PD-L1 inhibitors who received sacituzumab govitecan in the first-line setting (n = 279) experienced a statistically significant and clinically meaningful 38% reduction in the risk of disease progression or death compared with patients who received standard-of-care chemotherapy (n = 279).

What is the regulatory status of Dato-DXd in Europe for TNBC?

On June 26, 2026, the EMA’s CHMP issued a positive opinion recommending the approval of first-line datopotamab deruxtecan (Datroway; Dato-DXd) monotherapy for adult patients with unresectable or metastatic TNBC who are ineligible to receive PD-1/PD-L1 inhibitor therapy.⁵

This recommendation was backed by data from the phase 3 TROPION-Breast02 trial (NCT05374512). The primary readout of the study showed that the median PFS with Dato-DXd (n = 323) was 10.8 months (95% CI, 8.6-13.0) by BICR compared with 5.6 months (95% CI, 5.0-7.0) with investigator’s choice of chemotherapy (n = 321; HR, 0.57; 95% CI, 0.44-0.73; P < .0001).⁶ Moreover, the median overall survival (OS) with Dato-DXd was 23.7 months (95% CI, 19.8-25.6) vs 18.7 months (95% CI, 16.0-21.8) with investigator’s choice of chemotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .029).

References

1. DualityBio announces China NMPA acceptance of biologics license application seeking approval for trastuzumab pamirtecan for the treatment of unresectable or metastatic HER2-positive adult breast cancer. News release. DualityBio. April 9, 2026. Accessed July 15, 2026. http://en.dualitybiologics.com/news/605.html
2. Turner NC, Mayer EL, Park YH, et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): phase 3, double-blind ctDNA-guided SERENA-6 trial. J Clin Oncol. 2025;43(suppl 17):LBA4. doi:10.1200/JCO.2025.43.17_suppl.LBA4
3. Bidard FC, Mayer EL, Park YH, et al. First-line camizestrant for emerging ESR1-mutated advanced breast cancer. N Engl J Med. 2025;393(6):569-580. doi:10.1056/NEJMoa2502929
4. European Commission approves Trodelvy as a first-line treatment for metastatic triple-negative breast cancer patients not candidates for PD-(L)1 inhibitors. News release. Gilead. June 23, 2026. Accessed July 15, 2026. https://investors.gilead.com/news/news-details/2026/European-Commission-Approves-Trodelvy-as-a-First-Line-Treatment-for-Metastatic-Triple-Negative-Breast-Cancer-Patients-Not-Candidates-for-PD-l1-Inhibitors/default.aspx
5. Datroway recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic triple negative breast cancer who are not candidates for immunotherapy. News release. Daiichi Sankyo. June 26, 2026. Accessed July 15, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202606/20260626_E.pdf
6. Dent R, Shao Z, Schmid P, et al; TROPION-Breast02 investigators. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial. Ann Oncol. Published online April 3, 2026. doi:10.1016/j.annonc.2026.03.008