FDA Grants Priority Review for Genentech’s Tecentriq for a Certain Type of Stage III Colon Cancer
Filing acceptance is based on the Phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone
Nearly one in three patients with stage III colon cancer relapse within five years, highlighting a critical need for new adjuvant treatment options
If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumor characterized by high mutation rates. The FDA has granted Priority Review and is expected to make a decision on the approval by October 9, 2026.
