FDA Approves New Breast Cancer Drug Revtorpyk

Key Takeaways

• FDA approved gedatolisib (REVTORPYK, Celcuity) with fulvestrant ± palbociclib on July 14, 2026 for HR+/HER2- PIK3CA wild-type advanced breast cancer after endocrine therapy in the metastatic setting.
• VIKTORIA-1 showed median PFS of 9.3 months (triplet) and 7.4 months (doublet) versus 2.0 months with fulvestrant alone.
• REVTORPYK is described as the first FDA-approved pan–class I PI3K plus mTORC1/mTORC2 inhibitor.
• Celcuity expects late-Q3 2026 commercial launch and a Q3 2026 sNDA for PIK3CA-mutated disease.

REVTORPYK (gedatolisib) at a glance

Field	Detail
Drug	REVTORPYK (gedatolisib)
Company	Celcuity Inc.
FDA action	Approval on July 14, 2026
Indication	HR+/HER2- locally advanced or metastatic breast cancer without detected PIK3CA mutation, after ≥1 endocrine line in metastatic setting; with fulvestrant ± palbociclib
Class	Pan–class I PI3K (α, β, δ, γ) and mTORC1/mTORC2 inhibitor
Pivotal trial	VIKTORIA-1 Study 1 (NCT05501886); 392 patients randomized 1:1:1
Key PFS	Triplet 9.3 mo vs fulvestrant 2.0 mo (HR 0.24); doublet 7.4 mo (HR 0.33)

What did the FDA approve?

On July 14, 2026, the FDA approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib. The labeled population is adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected, after progression on or after at least one line of endocrine therapy in the metastatic setting.

Full details are on the agency's oncology approval notice: FDA's July 14 gedatolisib approval page.

How was VIKTORIA-1 designed?

Efficacy came from Study 1 of VIKTORIA-1 (NCT05501886 on ClinicalTrials.gov), an open-label, randomized, multicenter Phase 3 trial. It enrolled 392 adults with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer after CDK4/6 inhibitor and aromatase inhibitor therapy.

Patients were randomized 1:1:1 to gedatolisib plus fulvestrant and palbociclib (Arm A), gedatolisib plus fulvestrant (Arm B), or fulvestrant alone (Arm C). The primary endpoint was progression-free survival by blinded independent central review (RECIST 1.1). Secondary measures included overall survival, objective response rate, and duration of response.

What efficacy did VIKTORIA-1 show?

Per the FDA summary and Celcuity's SEC-furnished release:

• Arm A vs Arm C: median PFS 9.3 months (95% CI 7.2–16.6) vs 2.0 months (95% CI 1.8–2.3); HR 0.24 (95% CI 0.17–0.35); p<0.0001.
• Arm B vs Arm C: median PFS 7.4 months (95% CI 5.5–9.9) vs 2.0 months; HR 0.33 (95% CI 0.24–0.48); p<0.0001.
• ORR in measurable disease: 32% (Arm A), 28% (Arm B), 1% (Arm C).
• Median duration of response: 17.5 months (Arm A) and 12.0 months (Arm B).

Peer-reviewed primary results for the PIK3CA wild-type cohort were published in the Journal of Clinical Oncology (Hurvitz et al., 2026; PMID 41802242). Celcuity's company announcement is in Celcuity's July 14 SEC Exhibit 99.1.

Why does PIK3CA wild-type status matter?

Several approved PI3K-pathway drugs target PIK3CA-mutated disease. Celcuity said about 60% of HR+/HER2- advanced breast cancers are PIK3CA wild-type, so they are outside those mutation-restricted labels.

REVTORPYK is positioned as the first FDA-approved therapy that inhibits all class I PI3K isoforms and both mTOR complexes. That is Celcuity's and the FDA label context for mechanism; it does not mean superior outcomes versus every other second-line option in head-to-head trials outside VIKTORIA-1's control arm.

What are the next commercial and regulatory steps?

Celcuity said it anticipates commercial launch in late Q3 2026 and has an expanded-access path before launch for eligible patients. The company plans a Q3 2026 sNDA for HR+/HER2- PIK3CA-mutated disease based on the VIKTORIA-1 mutant cohort presented at ASCO 2026.

VIKTORIA-2 (NCT06757634) is ongoing in first-line advanced settings. Overall survival data from VIKTORIA-1 Study 1 remain immature in the published primary analysis; follow-up continues.

What remains uncertain?

Mature OS benefit is not yet established in the published primary analysis. Real-world tolerability of pan-PAM inhibition — including stomatitis and neutropenia rates seen with the triplet — will matter after launch. The PIK3CA-mutated indication is not yet approved; it depends on a future sNDA review.

For broader U.S. oncology and AI-care context on this beat, see sepsis AI and real-time data needs and our note on FDA human-factors guidance.

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Frequently Asked Questions

Primary Sources

1. FDA: Approves gedatolisib (Revtorpyk) — July 14, 2026
2. SEC: Celcuity Exhibit 99.1 — FDA approval of REVTORPYK
3. ClinicalTrials.gov: VIKTORIA-1 (NCT05501886)
4. PubMed: Hurvitz et al., J Clin Oncol 2026 (VIKTORIA-1 WT cohort)