FDA Approves Gedatolisib for HR-Positive, HER2-Negative Advanced Breast Cancer

Verified key facts

• The FDA approved gedatolisib (Revtorpyk, Celcuity) on 14 July 2026 for certain HR-positive, HER2-negative advanced breast cancers.
• It is cleared with fulvestrant, with or without palbociclib, for PIK3CA wild-type disease after progression on endocrine therapy.
• In the Phase 3 VIKTORIA-1 trial, the three-drug regimen cut the risk of progression or death by 76% versus fulvestrant alone.
• The drug targets class I PI3K isoforms and mTOR complexes mTORC1 and mTORC2.

A new option for advanced breast cancer

The US Food and Drug Administration has approved a new breast cancer treatment. According to the FDA, gedatolisib was cleared on 14 July 2026. It is marketed as Revtorpyk by Celcuity.

The approval covers a specific patient group. It applies to adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. Crucially, the disease must be PIK3CA wild-type, meaning without a detected PIK3CA mutation.

The drug is approved in combination with fulvestrant, with or without palbociclib. It is intended for use after disease progression on at least one line of endocrine therapy in the metastatic setting. The FDA set out these conditions in its approval.

How the drug works

Gedatolisib is described as a multi-target inhibitor. The company says it is the only approved inhibitor of class I PI3K isoforms alpha, beta, delta and gamma together with the mTOR complexes mTORC1 and mTORC2.

That broad mechanism sets it apart from some existing targeted therapies. Many drugs in this space hit a single pathway. Gedatolisib acts on several nodes of the PI3K/AKT/mTOR signalling network at once.

This network is central to how many cancer cells grow. Blocking it aims to slow or halt tumour progression. The approach reflects years of research into these signalling pathways in breast cancer.

The trial evidence

The approval rests on the Phase 3 VIKTORIA-1 trial. Celcuity reported that the three-drug regimen produced a striking result. It combined gedatolisib with palbociclib and fulvestrant.

In that group, the risk of disease progression or death fell by 76% compared with fulvestrant alone. The two-drug regimen of gedatolisib plus fulvestrant reduced the same risk by 67%. Both comparisons were among PIK3CA wild-type patients.

These figures describe relative risk reduction in a trial population. They do not promise the same outcome for every patient. Individual response depends on many factors that a treating oncologist must weigh.

• Approved 14 July 2026 for HR-positive, HER2-negative advanced breast cancer
• Restricted to PIK3CA wild-type disease after prior endocrine therapy
• Three-drug regimen cut progression or death risk by 76% in VIKTORIA-1
• Two-drug regimen cut the same risk by 67%

Where it fits in treatment

Breast cancer treatment has grown increasingly precise. Testing for markers such as HER2 status and PIK3CA mutations now guides therapy choices. Gedatolisib's label reflects that biomarker-driven approach.

By targeting PIK3CA wild-type disease specifically, the drug fills a defined niche. Patients with PIK3CA mutations already have other targeted options. This approval addresses a group with different tumour biology.

Oncology Nursing News and CancerNetwork both reported on the approval and its implications for care teams. Coverage emphasised the need for clinicians to understand the eligibility criteria. Correct patient selection is central to the drug's use.

What may come next

Celcuity has signalled plans to broaden the drug's reach. It said it planned to submit a supplemental application in the third quarter of 2026. That filing would seek approval for PIK3CA-mutated advanced breast cancer.

If successful, that would extend the drug beyond the wild-type population. For now, the approval is limited to the group defined in the current label. Any expansion would require its own regulatory review.

As with any cancer therapy, treatment decisions are highly individual. Patients should discuss options, benefits and potential side effects with their oncology team. This report describes a regulatory approval, not medical advice for any specific person.

The approval adds to a steady stream of oncology decisions from the FDA this summer. It reflects the continuing shift toward therapies matched to tumour genetics. For eligible patients, it widens the menu of available treatments.

Sources

• FDA - FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative breast cancer (14 July 2026)
• Celcuity via GlobeNewswire - Celcuity Announces FDA Approval of REVTORPYK (gedatolisib) (14 July 2026)
• Oncology Nursing News - FDA Approves Gedatolisib for HR+/HER2- Advanced Breast Cancer