Roche Drug Gets FDA Breakthrough Therapy Status

Roche has received a second Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A.The designation was granted for the treatment of people with PD-L1-positive (programmed death-ligand 1) non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. The FDA granted the first breakthrough therapy designation for MPDL3280A in metastatic bladder cancer in 2014. Ongoing studies of MPDL3280A include lung and bladder cancer, and the company plans to initiate Phase III studies in additional tumor types this year.

MPDL3280A (also known as anti-PDL1 and RG7446) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1. MPDL3280A is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.

Source: Roche

Leave a Reply

Your email address will not be published. Required fields are marked *