FDA accepted supplemental BLA filing for adjuvant Tecentriq and Tecentriq Hybreza in combination with chemo in stage III dMMR or MSI-H colon cancer and granted Priority Review; PDUFA: 9 October 2026
“This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery.”
Share:
More News
Reagan Jarvis, co-founder and Chief Executive Officer of Anocca, said: “The dosing of patients marks an important milestone for Anocca, and demonstrates our ability to develop, manufacture and clinically deploy precision TCR-T cell therapy products. The novel ANOC-001 clinical candidate was developed with Anocca’s proprietary analytical platform that maps targets
“The clinical experience in 81 patients validates both EBTATE and the broader Evans Blue platform,” said Chris Pak, Chairman and Chief Executive Officer of MTTI. “By improving tumor delivery and retention while requiring only approximately 12.5% of the cumulative radioactivity administered in current standard-of-care PRRT, the platform has the potential
Leslie Chong, Managing Director and CEO of Imugene, commented: “FDA Fast Track Designation for both CLL/SLL and MZL reflects the meaningful clinical activity we are seeing with azer-cel across multiple B-cell malignancies. For patients who have exhausted standard treatment options in these indications, we believe azer-cel represents a genuinely promising
“Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered,” said Olivier Nataf, Global Head of Oncology at Sanofi. “Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the