FDA Flashback: Breast Cancer Decisions and News From July 2026

Catch a glimpse of the breast cancer–related FDA decisions and announcements from July 2026, including the first approval of a combination containing a pan-class I PI3K and mTOR inhibitor for hormone receptor–positive, HER2-negative advanced disease, the clearance of another pegfilgrastim biosimilar for supportive care, the granting of tentative approval to a bioequivalent formulation of olaparib, and the finalization of 3 guidance documents intended to broaden eligibility for oncology clinical trials.

What is the significance of the FDA approval of gedatolisib plus fulvestrant, with or without palbociclib, for hormone receptor–positive, HER2-negative advanced breast cancer?

On July 14, 2026, the FDA approved gedatolisib (Revtorpyk) in combination with fulvestrant (Faslodex), with or without palbociclib (Ibrance), for the treatment of adult patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation following progression on or after at least 1 line of endocrine therapy in the metastatic setting.¹

This regulatory decision was supported by data from the PIK3CA wild-type cohort (Study 1) of the phase 3 VIKTORIA-1 trial (NCT05501886), which were presented at the 2025 ESMO Congress. Patients who received the triplet of gedatolisib plus fulvestrant and palbociclib (n = 131) achieved a median progression-free survival (PFS) of 9.3 months (95% CI, 7.2-16.6) compared with 2.0 months (95% CI, 1.8-2.3) among those given fulvestrant alone (n = 131; adjusted HR, 0.24; 95% CI, 0.17-0.35; P < .0001).^1,2 Patients treated with the doublet of gedatolisib plus fulvestrant (n = 130) had a median PFS of 7.4 months (95% CI, 5.5-9.9), also reflecting a significant reduction in the risk of disease progression or death vs fulvestrant monotherapy (HR, 0.33; 95% CI, 0.24-0.48; P < .0001). The recommended dosage of gedatolisib is 180 mg administered as an intravenous infusion over 30 minutes once weekly on days 1, 8, and 15 of every 28-day cycle. The application was reviewed under the FDA’s Real-Time Oncology Review program.¹

Watch Adam M. Brufsky, MD, PhD, of the University of Pittsburgh Medical Center Hillman Cancer Center, discuss the significance of the approval:

What is important to note about the FDA approval of the pegfilgrastim biosimilar pegfilgrastim-pccg (Ennumo)?

On July 10, 2026, the FDA approved pegfilgrastim-pccg, a biosimilar referencing pegfilgrastim (Neulasta), to decrease the incidence of infection, as manifested by febrile neutropenia, in adult and pediatric patients with non-myeloid malignancies who are receiving myelosuppressive anticancer agents associated with a clinically significant incidence of febrile neutropenia.³ The biosimilar is approved for all indications of reference pegfilgrastim, which also include increasing survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

What is the regulatory status of bioequivalent olaparib?

On July 20, 2026, a bioequivalent formulation of olaparib received FDA tentative approval for use across all previously approved indications of the reference product, olaparib (Lynparza).⁴ The tentative approval was granted for generic olaparib tablets in 100-mg and 150-mg strengths.

In breast cancer, the PARP inhibitor is approved for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative, high-risk early disease, as well as for patients with germline BRCA-mutated, HER2-negative metastatic disease.⁵

What guidance did the FDA finalize regarding cancer clinical trial eligibility criteria?

On July 27, 2026, the FDA’s Oncology Center of Excellence issued 3 final guidance documents intended to broaden the eligibility criteria for participation in clinical trials evaluating oncology drugs, with the documents addressing performance status, washout periods and concomitant medications, and laboratory values.^6,7,8,9 Each document finalizes a draft first issued in April 2024. According to the FDA, fewer than 5% of patients with cancer who are currently receiving treatment are enrolled in clinical trials, despite more than 70% of patients reporting willingness to participate in trials. The guidances aim to address the stringent and complex eligibility criteria that can impede enrollment.

The performance status guidance recommends expanding criteria to include patients across a wider range of performance statuses and outlines alternative trial designs, such as prespecified cohorts for patients with a lower performance status. The washout periods and concomitant medications guidance encourages sponsors to evaluate whether time-based washout periods are needed for a given study and makes some allowances for patients who are receiving other medications. The laboratory values guidance calls for a more scientific, safety-focused approach to the test thresholds used to determine eligibility.

References

1. FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer. FDA. July 14, 2026. Accessed August 6, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally
2. Revtorpyk. Prescribing information. Celcuity; July 2026. Accessed August 6, 2026. https://www.celcuity.com/wp-content/uploads/2026/04/REVTORPYK_PI_2026.pdf
3. FDA approves Ennumo (pegfilgrastim-pccg), Accord BioPharma’s second pegfilgrastim biosimilar to Neulasta (pegfilgrastim). News release. Accord BioPharma. July 9, 2026. Accessed August 6, 2026. https://www.biospace.com/press-releases/fda-approves-ennumo-pegfilgrastim-pccg-accord-biopharmas-second-pegfilgrastim-biosimilar-to-neulasta-pegfilgrastim
4. NATCO receives tentative approval for olaparib tablets from the United States Food and Drug Administration (U.S. FDA). News release. NATCO Pharma. July 20, 2026. Accessed July 21, 2026. https://www.natcopharma.co.in/insights/news-and-announcements
5. Lynparza. Prescribing information. AstraZeneca; July 2025. Accessed August 6, 2026. https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/00997c3f-5912-486f-a7db-930b4639cd51/00997c3f-5912-486f-a7db-930b4639cd51_viewable_rendition__v.pdf
6. Final guidances to expand participation in cancer clinical trials. FDA Oncology Center of Excellence. July 2026. Accessed August 6, 2026. https://www.fda.gov/about-fda/oncology-center-excellence/oncology-center-excellence-guidance-documents
7. Cancer clinical trial eligibility criteria: performance status. FDA. August 6, 2026. Accessed July 27, 2026. https://www.fda.gov/media/178018/download
8. Cancer clinical trial eligibility criteria: washout periods and concomitant medications. FDA. July 27, 2026. Accessed August 6, 2026. https://www.fda.gov/media/178016/download
9. Cancer clinical trial eligibility criteria: laboratory values. FDA. August 6, 2026. Accessed July 27, 2026. https://www.fda.gov/media/178013/download