Pfizer and Celcuity have reached a partnership to develop PI3K for breast cancer...

Compileriver

On April 8, according to foreign media reports, cell analysis company Celcuity announced that it has reached a global license agreement with Pfizer.

Under the terms of the license agreement, Pfizer provided Celcuity with a global license to develop and commercialize gedatolisib.

Patients with estrogen receptor-positive ER+/HER2- metastatic tumors usually receive endocrine therapy, such as tamoxifen, letrozole, or fulvestrant.

In order to evaluate the efficacy and safety of this new treatment strategy, an extension of the Phase 1b clinical trial is currently being conducted in patients with ER+/HER2-negative advanced or metastatic breast cancer, combining gedatolisib with the oral CDK 4/6 inhibitor palbociclib Letrozole or Fulvestrant are evaluated.

Art DeCillis, MD, Chief Medical Officer of Celcuity, said: “In view of the reported data as of January 11, 2021, we intend to initiate a review of ER+/HER2-advanced or metastatic breast cancer patients in the first half of 2022 based on feedback from the FDA.

Reference source:

1.