Search
Close this search box.

FDA Grants Fast Track Designation to TTI-101 for Hepatocellular Carcinoma

“We are pleased to receive Fast Track designation for TTI-101 in HCC from the FDA,” said Imran Alibhai, PhD, CEO of Tvardi. “This designation provides validation of the compelling safety and efficacy we have seen in last-line HCC patients in our Phase 1 trial. This comes at a perfect time as we look forward to enrolling patients imminently in our Phase 2 HCC basket trial which will test TTI-101 as monotherapy and in combination with existing approved therapies across first-, second-, and last-line HCC patients.”

Share:

More News

“Cancer, a leading cause of death worldwide, exacts an immense toll on individuals, families, and communities. No person, family, scientist, clinician, hospital, policy maker, company or country can or should face this devastating disease alone. We all must work together to win, which is why we are committed to playing

“Our encouraging Phase 2 data for GRANITE in MSS-CRC continue to mature and demonstrate durable benefit over time. With two additional months of follow-up, relative progression-free survival has further improved in the analysis of all patients treated with GRANITE, and most notably, in those with a lower tumor burden at

“Patients in the EU with ROS1 -positive non-small cell lung cancer and NTRK -positive solid tumors face a great unmet need for new therapies that may improve their outcomes and address or delay the difficult issue of treatment resistance,” said Joseph Fiore, vice president, global program lead, repotrectinib, Bristol Myers

“The acquisition of Biotheus builds on our successful ongoing collaboration on BNT327/PM8002 and other investigational bispecific antibodies,” said Prof. Ugur Sahin, M.D., Ph.D., CEO and co-founder of BioNTech. “We believe that BNT327/PM8002 has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors.