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

“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,

“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to

“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look

“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are