Sorrento Therapeutics shares are trading high following FDA clearance of IND for Abivertinib in metastatic castrate resistant prostate cancer (mCRPC)

Sorrento Therapeutics, Inc. SRNE received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug application (IND) of Abivertinib (Fujovee) for patients with metastatic castrate resistant prostate cancer (mCRPC) in the Phase 2 MAVERICK clinical study.

The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium, to evaluate the efficacy of Abivertinib with abiraterone via an assessment of 6-month radiographic progression-free survival (rPFS).

Sorrento is planning to enrol 100 participants with both abiraterone-naïve and abiraterone-progressing mCRPC.

The primary endpoint is the 6-month rPFS defined as a percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases.

Sorrento Therapeutics is trading high 5 percent at $1.52