Pfizer's Selective CDK4 Inhibitor PF-07220060 Receives IND Approval in China for Advanced Solid Tumors

On January 26, the CDE website showed that Pfizer's PF-07220060 clinical trial application was approved for the treatment of advanced solid tumors. This is the world's first CDK4 inhibitor to enter the clinical stage and is currently in Phase I clinical trials in the United States.

PF-07220060 is a CDK4 (cyclin-dependent kinase 4) inhibitor developed by Pfizer. It can reduce the proliferation of cancer cells by blocking tumor cells from entering the S phase from the G1 phase. Pfizer's disclosed product pipeline includes four CDK inhibitors: the CDK4/6 inhibitor Ibrance (palbociclib), the CDK2/4/6 inhibitor PF-06873600, the CDK4 inhibitor PF-07220060, and the CDK2 inhibitor PF-07104091.

Currently, five CDK4/6 inhibitors have been launched globally: Ribociclib (Novartis), Palbociclib (Pfizer), Trilaciclib (G1 Therapeutics, Simcere Pharmaceutical holds the rights in Greater China), Dalpiciclib (Hengrui), and Abemaciclib (Eli Lilly).

Three CDK4/6 inhibitors have been launched in China. Apart from Pfizer and Eli Lilly, Hengrui's dalpiciclib was launched on December 31, 2021, in combination with fulvestrant, for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative recurrent or metastatic breast cancer who experienced disease progression after prior endocrine therapy. In addition, Qilu Pharmaceutical's generic version of palbociclib was also launched in December 2020.

Globally, no CDK4 inhibitors have been approved for marketing. Apart from Pfizer's PF-07220060, Roche has also developed two CDK4 inhibitors, both in the preclinical stage.