Brian Park, PharmD

The Hepzato Kit (melphalan/hepatic delivery system) is approved as a liver-directed treatment for adults with metastatic uveal melanoma and unresectable hepatic metastases.

Magrolimab is an investigational monoclonal antibody that binds to CD47.

Suflave is expected to be available in early August 2023.

Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed with a novel 2:1 structural format.

Lynparza is a poly polymerase inhibitor.

RRx-001 is an investigational small molecule inflammasome NLRP3 inhibitor and Nrf2 upregulator with antioxidant and anti-inflammatory properties.

Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.

The sBLA is supported by data from the phase 3 CheckMate -76K trial which included 790 patients after complete resection of stage IIB or IIC melanoma.

Nirogacestat is an oral, selective, small molecule gamma-secretase inhibitor that works by blocking proteolytic activation of Notch receptors.

The application is supported by data from a phase 3 study evaluating niraparib plus AAP as first-line treatment in patients with mCRPC with or without alterations in HRR associated genes.