US FDA approves Celcuity's breast cancer drug [View all]

July 14 (Reuters) - The U.S. FDA has approved Celcuity's drug for an ‌advanced form of breast cancer, ‌the regulator said on Tuesday, making it the company's ​first product to gain market entry and sending its shares up 7% in afternoon trading.

The U.S. Food and Drug ‌Administration's approval was ⁠based on late-stage data showing the drug, gedatolisib, branded as ⁠Revtorpyk, when combined with Pfizer's Ibrance and fulvestrant, reduced the risk of disease ​progression or ​death by 76% ​compared with fulvestrant ‌alone.

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.

https://www.yahoo.com/news/science/articles/us-fda-approves-celcuitys-breast-193742875.html?fr=sycsrp_catchall