FDA Flashback: Breast Cancer Decisions and News From June 2026

Catch a glimpse of the breast cancer–related FDA decisions and announcements granted in June 2026, including several practice-changing approvals, the granting of priority review to an oral selective estrogen receptor degrader (SERD), and recommended practices for conserving breast biopsy needle supply in response to shortages.

What is the significance of the FDA approval of palbociclib (Ibrance) plus trastuzumab (Herceptin) with or without pertuzumab (Perjeta) and endocrine therapy as maintenance for hormone receptor–positive, HER2-positive metastatic breast cancer?

On June 24, 2026, the FDA approved palbociclib plus trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance therapy for adult patients with hormone receptor–positive, HER2-positive locally advanced or metastatic breast cancer after induction therapy.¹

This regulatory decision was backed by findings from the phase 3 PATINA trial (NCT02947685), in which palbociclib plus trastuzumab, with or without pertuzumab, and endocrine therapy generated a significant investigator-assessed progression-free survival (PFS) benefit vs trastuzumab, with or without pertuzumab, and endocrine therapy (HR, 0.76; 95% CI, 0.59-0.97; 1-sided P = .0134).

What is important to note about the FDA approvals of sacituzumab govitecan-hziy (Trodelvy) for first-line triple-negative breast cancer (TNBC)?

On June 24, 2025, the FDA also approved 2 indications for first-line sacituzumab govitecan in adult patients with TNBC:²

• As monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor–based therapy.
• In combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (combined positive score ≥ 10) as determined by an FDA-authorized test.

The monotherapy approval was informed by findings from the phase 3 ASCENT-03 trial (NCT05382299), in which patients who received sacituzumab govitecan had a median PFS of 9.7 months (95% CI, 8.1-11.1) compared with 6.9 months (95% CI, 5.6-8.2) in those treated with chemotherapy (HR, 0.62; 95% CI, 0.50-0.77; P < .0001). The confirmed overall response rates (ORRs) were 50% (95% CI, 44%-56%) and 47% (95% CI, 41%-53%), respectively.

The combination approval was supported by findings from the phase 3 ASCENT-04/KEYNOTE-D19 trial (NCT05382286), in which the median PFS among patients in the sacituzumab govitecan arm was 11.2 months (95% CI, 9.3-16.7) vs 7.8 months (95% CI, 7.3-9.3) among those in the control arm, who received physician’s choice of chemotherapy plus pembrolizumab (HR, 0.65; 95% CI, 0.51-0.84; P = .0009). The respective confirmed ORRs were 61% (95% CI, 55%-68%) vs 55% (95% CI, 48%-62%).

“The data we’ve seen with the combination are a significant improvement and a clinically meaningful one, and so will be important for patients to have access to newer treatments,” Sara M. Tolaney, MD, MPH, of Dana-Farber Cancer Institute and Harvard Medical School in Boston, Massachusetts, said in an interview with OncLive®.

Is there a companion diagnostic for inavolisib (Itovebi) use in hormone receptor–positive, HER2-negative, PIK3CA-mutated breast cancer?

On June 4, 2026, the FDA approved the FoundationOne CDx for use as a companion diagnostic for the use of inavolisib plus palbociclib and fulvestrant (Faslodex) for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.³ Notably, this treatment combination is approved for use in this patient population with PIK3CA mutations detected by an FDA-approved test following recurrence on or after the completion of adjuvant endocrine therapy.⁴

What is the regulatory status of giredestrant for estrogen receptor (ER)–positive early breast cancer?

On June 4, 2026, the FDA also granted priority review to a new drug application (NDA) seeking the approval of the oral SERD, giredestrant in the adjuvant setting for the treatment of adult patients with ER-positive, HER2-negative, stage I to III breast cancer.⁵ The regulatory agency assigned a Prescription Drug User Fee Act target action date of November 30, 2026.

This NDA was backed by findings from the phase 3 lidERA Breast Cancer trial (NCT04961996), in which adjuvant giredestrant reduced the risk of invasive disease recurrence or death compared with standard-of-care (SOC) endocrine therapy by 30% in patients with medium- or high-risk stage I to III ER-positive, HER2-negative early-stage breast cancer (HR, 0.70; 95% CI, 0.57-0.87; P = .0014). At the 3-year analysis, 92.4% of patients who received giredestrant were alive and free of invasive disease vs 89.6% of those who received SOC endocrine therapy.

“The data were significant,” MinhTri Nguyen, MD, of Rush MD Anderson Cancer Center in Chicago, Illinois, said in an episode of the Breast Cancer Briefing podcast, hosted by Sara Nunnery, MD, MSCI, of Tennessee Oncology in Nashville. “I wouldn’t say they were extremely surprising. We had some hints of this already [in] phase 2 trials. One thing with the clinical trial design is it doesn’t reflect what our current practice is today, unfortunately. My concern with this is that we can’t easily relate [the lidERA Breast Cancer regimen] to what we currently do, which includes CDK4/6 inhibitors.”

Watch the full video podcast for the full conversation or listen on any of your favorite podcast platforms!

What is the regulatory status of TER-2013 for breast cancer?

On June 3, 2026, the FDA granted fast track designation to the AKT1-selective small molecule inhibitor TER-2013 for the treatment of patients with locally advanced, unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer harboring at least 1 AKT/PI3K/PTEN alteration after progression on 1 or more endocrine-based therapies and CDK4/6 inhibitors for advanced disease.⁶ TER-2013 is under investigation in a phase 1 first-in-human trial (NCT07109726) in patients with solid tumors harboring AKT/PI3K/PTEN pathway alterations. The dose-escalation portion of the trial is complete, and the trial is ongoing to select the optimal dose for expansion.

What is the status of breast biopsy needle supply in the US?

On June 16, 2026, the FDA announced that the US is undergoing interruptions in the supply of stereotactic breast biopsy needles due to recent supplier issues.⁷ The regulatory agency noted that this disruption may affect patient care and require adjustments to breast biopsy practices. The duration of this shortage is expected to last through the end of March 2027.

The FDA recommends that health care providers consider implementing strategies to conserve the use of stereotactic breast biopsy needles, including:

• Expanding supplier networks through diversification of vendors
• Diversifying and using all needle lengths and gauges
• Using prior-generation devices when clinically appropriate
• Limiting opening or wasting devices unnecessarily

Health care providers are also being counseled to regularly monitor needle biopsy inventories and transparently communicate these manufacturing delays to patients.

References

1. FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer. FDA. June 24, 2026. Accessed July 8, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance
2. FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer. FDA. June 24, 2026. Accessed July 8, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line?utm_medium=email&utm_source=govdelivery
3. US Food and Drug Administration approves FoundationOne CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. News release. Foundation Medicine. June 2, 2026. Accessed July 8, 2026. https://www.foundationmedicine.com/press-release/fda-foundationone-cdx-itovebi
4. FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. FDA. October 10, 2024. Accessed July 8, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive
5. FDA accepts new drug application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting. News release. Roche. July 8, 2026. Accessed June 4, 2026. https://www.roche.com/media/releases/med-cor-2026-06-02
6. Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1-selective small molecule inhibitor for breast cancer. News release. Terremoto Biosciences. June 3, 2026. Accessed July 8, 2026. https://terremotobio.com/press-release/terremoto-biosciences-granted-fda-fast-track-designation-for-ter-2013-an-akt1-selective-small-molecule-inhibitor-for-breast-cancer/
7. Disruptions in availability of breast biopsy needles - letter to health care providers. FDA. June 16, 2026. Accessed July 8, 2026. https://www.fda.gov/medical-devices/letters-health-care-providers/disruptions-availability-breast-biopsy-needles-letter-health-care-providers