On July 14, 2026 the FDA approved Revtorpyk (gedatolisib) + fulvestrant, with or without palbociclib, for HR+/HER2−, PIK3CA wild-type advanced breast cancer after prior endocrine therapy. Basis: the Phase III VIKTORIA-1 trial (Celcuity, $CELC).
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Gedatolisib is now @US_FDA ✅ based off VIKTORIA-1: PhIII, Gedato (PI3K/mTORi) + Fulv +/- Palbo vs. Fulv in HR+ after one line of ET in HR+ - mPFS: 9.3mos w/triplet vs. single agent Fulv (HR: 0.24) - mPFS: 7.4mos w/doublet vs. single agent Fulv (HR: 0.33) - AEs (IV/⏰ https://t.co/VdkLGBgPu2
This is for PIK3CA-WT. Comparing triplet (Arm A) and doublet (Arm B) to single agent Fulvestrant (Arm C) (rather than this being compared to Alpelisib + Fulv). Thanks for pointing this out @dr_yakupergun 🙏🏽🙏🏽
The @FDA approves gedatolisib as 2nd line therapy in combo with fulvestrant in tumors w/o PIK3CA mutations. Median PFS F, 2.0m, F+G, 7.4m, F+G+palbo 9.3m. https://t.co/VPzVX3Wglb
FDA approves gedatolisib in combination with fulvestrant, with or without palbociclib, for adults with HR+/HER2-locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy
FDA approved gedatolisib (Revtorpyk) + fulvestrant ± palbociclib for HR+/HER2−, PIK3CA wild-type advanced/metastatic breast cancer after progression on endocrine therapy. @Larvol @OncoAlert https://t.co/N9n8lbH21I
Treatment algorithm in outline for ER+ MBC: Column A: endocrine agent (fulvestrant, oSERD, AI, tamoxifen) Column B: targeted agent (CDK46i, PIK3CAi) Choose one from column A and one from column B. Repeat with each line of treatment.
Posts by physicians about VIKTORIA-1, newest first: ESMO 2026 week (October 17–24, 2026), then earlier posts from the ESMO 2025 wild-type readout (October–December 2025). Approval-day posts are in the FDA Approval section. Each post is shown in full and verbatim and linked to the original on X.
𝕏#ESMO26 | VIKTORIA-1 – Study 2 In PIK3CA-mutant HR+/HER2− advanced breast cancer after CDK4/6i, gedatolisib + palbociclib + fulvestrant showed a PFS benefit over alpelisib + fulvestrant in patients with visceral metastases (9.8 vs 5.6 months; HR 0.52) and liver metastases (9.1 vs 4.6 months; HR 0.47). Superiority over an active control and lower rates of hyperglycemia are important strengths. However, my main question remains the added contribution of palbociclib. Gedatolisib + fulvestrant also showed substantial activity; although the small doublet arm does not establish equivalence, it raises questions about the additional toxicity and cost of the triplet. Weekly IV administration and stomatitis remain practical limitations. Excluding patients previously treated with PI3K/AKT/mTOR inhibitors also limits applicability to contemporary treatment sequencing.
𝕏VIKTORIA-1 shows benefit of Gedatolisib + fulvestrant +/- palbociclib significantly improved median PFS across subgroups as compared to alpelisb+fulv (in second line after CDK4/6i) #ESMO26 @OncoAlert @BarbaraPistill2 https://t.co/ItKZeazGji
𝕏Bill Gradishar poses appropriate questions discussing VIKTORIA-1 #ESMO26 @OncoAlert https://t.co/4jwW7AA8c2
𝕏Updated results from VIKTORIA1 Study 2 confim PFS benefit. #ESMO26 Open questions from the Discussion @OncoAlert @BarbaraPistill2 https://t.co/V2kuf3V1iy
𝕏| VIKTORIA-1: Encouraging results in PIK3CA-mutated HR+/HER2− advanced breast cancer after CDK4/6i. Gedatolisib + fulvestrant ± palbociclib improved PFS vs alpelisib + fulvestrant, including in liver metastases. ▪️ORR: 43–59% vs 33% ▪️Median DoR: 19.4–27.8 vs 7.5 months ▪️Discontinuation of gedatolisib/alpelisib due to AEs: 4–5% vs 19% #ESMO26 @Larvol @myESMO @OncoAlert
𝕏VIKTORIA-1 #ESMO26 In PIK3CA-mutated HR+/HER2− advanced #BreastCancer post-CDK4/6i, gedatolisib-based regimens improved PFS vs alpelisib + fulvestrant, with fewer treatment discontinuations due to adverse events (4–5% vs 19%). @OncoAlert #bcsm @GustaveRoussy https://t.co/05cxWxH6M4
Metastatic HR+ #BreastCancer #SABCS highlights w/ @hoperugo: ✅ #AMBRE ✅ #MONALEESA ✅ #VIKTORIA1 ✅...
#SABCS25 Day 3 Highlights: 1. #AMBRE: 1L in high tumor burden HR+ mBC 2. #VIKTORIA1: 2L after ET/CDK 4-6i in HR+ mBC 3....
Benefit of gedatolisib in the VIKTORIA-1 trial was seen irrespective of duration of the immediate prior therapy. @BarbaraPistill2 #SABCS25
#VIKTORIA1: combos of gedatolisib (multi target inhibitor of PI3 and mTOR 1/2) in PI3 wt post CDK 4/6 ER+ #bcsm PFS Fulv - 2.0 mo Fulv/ged - 7.4 mo Fulv/palbo/ged...
Fantastic discussion at #ESMO25 by super @ALEDIGNUS12 on the complicated choices for second-line endocrine-based therapy in patients with advanced HR+/HER2-...
VIKTORIA-1: major improvement in PFS (9.3 vs 2 months, HR 0.24, p<0.001) with gedatolisib/palbo/fulvestrant vs fulvestrant as 2L after CDK4/6i for PIK3CAwt disease. Moderate toxicity, with 2...
#ESMO25 Sara Hurvitz presented the fascinating and important data from Victoria-1. The PIK3CA/mTOR IV inhibitor gedatolisib markedly increased PFS with palbo (and without) comp to...
4. #VIKTROIA1: PhIII, Gedatolisib (IV, PI3K/mTORi) + Fulv +/- Palbo vs. Fulv in HR+ after CdK4/6i - mPFS 9.3mos vs. 2.0mos triplet vs. Fulvestrant in WT (Fulv alone is not what we...
PFS (Study 1, wild-type) — Triplet 9.3 mo (95% CI 7.2-16.6) vs 2.0 mo, HR 0.24, p<0.0001; doublet 7.4 mo (5.5-9.9), HR 0.33, p<0.0001. (FDA label)
ORR — 32% (triplet) / 28% (doublet) / 1% (fulvestrant). (FDA label)
PIK3CA wild-type cohort (ESMO 2025): the gedatolisib triplet demonstrated a PFS HR of 0.24 (95% CI: 0.17–0.35) vs fulvestrant, a 76% reduction in the risk of disease progression or death. Median PFS was 9.3 months vs 2.0 months. The gedatolisib doublet showed PFS HR 0.33, a 67% risk reduction. PIK3CA-mutant cohort (May 1, 2026): positive topline announcement — both gedatolisib triplet and gedatolisib doublet improved PFS vs the alpelisib + fulvestrant active comparator. Primary results were presented at ASCO 2026, LBA1008 (Hurvitz; data cut-off March 9, 2026): median PFS by blinded independent central review was 11.1 months with the gedatolisib triplet vs 5.6 months with alpelisib + fulvestrant (HR 0.50; 95% CI 0.37–0.68; P<0.0001), and 11.3 vs 5.6 months with the gedatolisib doublet (HR 0.51; 95% CI 0.33–0.79; P=0.0013). Subgroup analyses by liver and visceral metastases from the same March 9, 2026 data cut-off were presented at ESMO 2026 (Pistilli); see the ESMO 2026 slides below. The PIK3CA-mutant indication is investigational.
OS data not yet reported in either cohort. Follow-up is ongoing; OS is a key secondary endpoint.
In the PIK3CA-WT cohort, hyperglycemia was notably lower than expected for a PI3K-pathway inhibitor (9.2% triplet, 11.5% doublet) — a key differentiator vs alpelisib. Other most-common AEs are consistent with the palbociclib + fulvestrant backbone (neutropenia, fatigue). In the PIK3CA-mutant cohort (ASCO 2026, LBA1008, data cut-off March 9, 2026), all-grade treatment-related hyperglycemia was 15.0% (triplet), 11.5% (doublet) and 57.9% (alpelisib + fulvestrant), grade 3: 2.6%, 0% and 13.8%; all-grade treatment-related stomatitis was 61.4%, 61.5% and 34.2%, grade 3: 16.3%, 5.8% and 5.3%. Discontinuation of assigned therapy due to treatment-related adverse events was 2.6%, 3.8% and 7.1%. At ESMO 2026 (same data cut-off), discontinuation of gedatolisib or alpelisib due to treatment-emergent adverse events was reported as 5%, 4% and 19%, respectively.
Regulatory status & clinical implications — FDA approved Jul 14, 2026 for HR+/HER2- PIK3CA wild-type only; the PIK3CA-mutant cohort (Study 2) is NOT part of the approval. (FDA.gov) The PIK3CA-mutant readout (topline May 1, 2026) was presented at ASCO 2026 (LBA1008), with subgroup analyses at ESMO 2026; in June 2026 Celcuity stated that it planned a supplemental NDA submission in Q3 2026. Use in PIK3CA-mutant disease remains investigational.
Sponsor / Drug — Celcuity; gedatolisib, a pan-PI3K/AKT/mTOR inhibitor, 180 mg IV weekly on Days 1/8/15 of each 28-day cycle. (FDA label)
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated October 24, 2026.
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May 1, 2026 — Celcuity ($CELC) announced that the Phase 3 VIKTORIA-1 trial achieved its primary endpoint in the PIK3CA-mutant cohort, joining the previously-reported positive PIK3CA-wild-type readout. Both gedatolisib triplet and doublet improved PFS vs the alpelisib + fulvestrant active comparator. Full data at ASCO 2026 (May 29–Jun 2). Update: presented June 2, 2026 at ASCO 2026 as LBA1008 (data cut-off March 9, 2026); see At a Glance.
Threads ranked by total KOL discussant count (replies + quote-tweets). Each main tweet shows the actual oncology KOL discussants — both replies (green) and quote-tweets (blue). Wall Street, stock-promo, WhatsApp-spam, analyst price-target tweets, and emoji-only replies all excluded.
BREAKING: positive results from the VIKTORIA-1 PIK3CA-mutant cohort Both the gedatolisib triplet and doublet improved PFS vs fulv/alpelisib, positioning gedatolisib as an active option irrespective of PIK3CA status. Key caveat: the weekly IV formulation. https://t.co/ZclPhQmcWl
The only agent with positive data in wild type and mutant BC since everolimus! Caveats as noted. IV 3 out of 4 weeks and stomatitis. @OncoAlert https://t.co/09ilVZ0pHG
We already knew the positive results in the PIK3CA-wild population. Seeing positive results in the mutant group as well is encouraging. The main drawback of the combination, however, is its parenteral administration: ➡
The incredible negative impact on LIVING while being tied to an infusion chair 3 weeks out of 4 means there has got to be way more than a statistically significant ⬆️ in PFS (which could be a month or so) - it better hav
VIKTORIA-1 is a Phase III, open-label, randomized trial evaluating gedatolisib — now FDA-approved as Revtorpyk — a pan-PI3K/mTORC1/2 inhibitor (Celcuity), in combination with fulvestrant ± palbociclib versus fulvestrant alone in adults with HR+/HER2- advanced breast cancer whose disease progressed on or after a CDK4/6 inhibitor and an aromatase inhibitor. The trial enrolls separate PIK3CA wild-type and PIK3CA-mutant cohorts, both of which reported positive primary-endpoint results: PIK3CA wild-type (presented at ESMO 2025 — the basis for the July 14, 2026 FDA approval) and PIK3CA-mutant (announced May 1, 2026; presented at ASCO 2026, LBA1008, with subgroup analyses at ESMO 2026). Gedatolisib is FDA-approved for the PIK3CA wild-type indication; its use in PIK3CA-mutant disease remains investigational; in June 2026 Celcuity stated that it planned a supplemental NDA submission in Q3 2026.
Design — Phase 3; gedatolisib (Revtorpyk) + fulvestrant, with or without palbociclib; Study 1 = PIK3CA wild-type vs single-agent fulvestrant (NCT05501886, n=392). (FDA label)
Phase III, global, open-label, randomized trial. The PIK3CA wild-type cohort randomized 1:1:1 to gedatolisib triplet (gedatolisib + palbociclib + fulvestrant), gedatolisib doublet (gedatolisib + fulvestrant), or fulvestrant alone. The PIK3CA-mutant cohort randomized 3:3:1 to gedatolisib triplet, alpelisib + fulvestrant (active comparator), or gedatolisib doublet.
Adults with HR+/HER2- locally advanced or metastatic breast cancer whose disease progressed on or after prior CDK4/6 inhibitor + aromatase inhibitor. Patients enrolled into separate PIK3CA wild-type or PIK3CA-mutant cohorts based on tumor genotype.
Gedatolisib 180 mg IV weekly (3 weeks on / 1 week off, 28-day cycle) + palbociclib 125 mg daily (21 of 28 days) + fulvestrant 500 mg IM (triplet); or gedatolisib + fulvestrant (doublet); or fulvestrant alone (control). PIK3CA-mutant cohort uses alpelisib + fulvestrant as the active comparator instead of fulvestrant alone.
Co-primary endpoints: PFS by blinded independent central review comparing (1) triplet vs control and (2) doublet vs control. Key secondary endpoints: overall survival, ORR, DoR, and patient-reported outcomes.
VIKTORIA-1 is Celcuity's Phase 3 trial of gedatolisib (Revtorpyk) plus fulvestrant, with or without palbociclib, in HR+/HER2- advanced breast cancer, with a PIK3CA wild-type cohort (Study 1, versus fulvestrant) and a PIK3CA-mutant cohort (Study 2, versus alpelisib plus fulvestrant). See Trial Design.
Yes. On July 14, 2026 the FDA approved gedatolisib (Revtorpyk) with fulvestrant, with or without palbociclib, for HR+/HER2- PIK3CA wild-type advanced breast cancer after at least one line of endocrine therapy. See FDA Approval.
Both gedatolisib regimens improved progression-free survival versus fulvestrant alone in Study 1 (triplet HR 0.24). Medians, confidence intervals and response rates: At a Glance.
No. The approval covers PIK3CA wild-type disease (Study 1) only; the PIK3CA-mutant cohort is a separate readout, and Celcuity plans a separate supplemental filing. See At a Glance.
Gedatolisib is developed by Celcuity and given intravenously once weekly on Days 1, 8 and 15 of each 28-day cycle. Dosing and label warnings: FDA Approval.
Updated October 24, 2026: The table groups posts by readout: the first 5 rows are reactions to the May 1, 2026 PIK3CA-mutant cohort (Study 2) topline announcement; the next 13 are posts from October–December 2025, after the ESMO 2025 PIK3CA wild-type cohort (Study 1) readout; the last 6 are ESMO 2026 Study 2 posts from October 24, 2026.
