FDA approves gedatolisib for breast cancer
The US FDA approved gedatolisib (Revtorpyk) on 14 July 2026 with fulvestrant, with or without palbociclib, for certain HR-positive, HER2-negative breast cancers.
Key points
- The US FDA approved gedatolisib (Revtorpyk, Celcuity) on 14 July 2026.
- It is used with fulvestrant, with or without palbociclib, in adults with HR-positive, HER2-negative breast cancer without a detectable PIK3CA mutation.
- The approval rests on the VIKTORIA-1 trial.
- This is a US decision; UK availability is decided separately.
What was announced
On 14 July 2026 the US Food and Drug Administration (FDA) approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib.
It is approved for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer that has no detectable PIK3CA mutation and has progressed after at least one line of endocrine therapy.
What it means
The FDA says efficacy was evaluated in VIKTORIA-1, an open-label study in which patients were randomly assigned to gedatolisib with fulvestrant and palbociclib, gedatolisib with fulvestrant, or fulvestrant alone.
The approval letter requires a further randomised trial to characterise known serious risks, including severe stomatitis and mucosal inflammation.
This is a US decision; availability in the UK is decided separately by the MHRA and NICE.
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