Nuvation Bio : FDA Clears IND Application For NUV-422 For Advanced Breast Cancer Treatment

(RTTNews) - Nuvation Bio Inc. (NUVB) said that the U.S. Food and Drug Administration has cleared its investigational new drug application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast cancer.

The FDA accepted the Company's first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM).

The company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer (mCRPC).

The company is continuing to enroll patients in the Phase 1 dose escalation portion of the study. It looks forward to sharing data from the Phase 1 dose escalation portion in the second half of 2022.

The company noted that it will be initiating a phase 1/2 study in patients with HR+/HER2- advanced breast cancer who have received prior hormonal therapy combined with an approved CDK 4/6 inhibitor.