HyperLocal Loop
Jul 14, 2026
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US FDA Approves Breast Cancer Drug

The US Food and Drug Administration (FDA) has approved Celcuity’s drug, gedatolisib, branded as Revtorpyk, for an advanced form of breast cancer. This approval is based on late-stage data showing that Revtorpyk, when combined with Pfizer’s Ibrance and fulvestrant, reduced the risk of disease progression or death by 76% compared with fulvestrant alone.

Treatment Details

Revtorpyk is intended to treat patients with advanced breast cancer whose tumors have low levels of a protein called HER2 and no mutation in a gene called PIK3CA, and whose disease has worsened after hormone therapy and a CDK inhibitor, a type of therapy. Patients receiving the combination remained progression-free for a median of 9.3 months, compared with 2.0 months for patients receiving fulvestrant alone.


Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.

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