July 15, 2026
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The FDA has approved a new targeted therapy combination for the most common subtype of breast cancer.Gedatolisib (Revtorpyk, Celcuity Inc.) plus fulvestrant, with or without palbociclib (Ibrance, Pfizer), was approved for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression during or after
July 15, 2026
2 min read
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Gedatolisib is approved in combination with fulvestrant, with or without palbociclib

Celcuity's Revtorpyk wins FDA approval for use in HR+/HER2- breast cancer without a PIK3CA mutation.

Revtorpyk was approved for women with advanced breast cancer whose disease worsened after previous hormone-based treatments;…

Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s…

The FDA has approved sacituzumab govitecan-hziy as first-line therapy for adults with unresectable locally advanced or metastatic…

The FDA has approved the first and only cyclin-dependent kinase 4/6 inhibitor for patients with HR-positive metastatic breast…

FDA approves breast cancer drug that cut progression risk by 76%