Global Ph 3 Clinical Trial for Cholangiocarcinoma Authorized in the EU and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by EMA

“We are thrilled to have dosed the first US patient in our Phase 3 trial and appreciate the effort and participation by clinicians and patient. It is also an important indicator of TransThera’s international clinical execution capabilities.” said Jean Fan, M.D., Chief Medical Officer of TransThera Sciences. “We will be committed to advancing the development of tinengotinib that has potential to demonstrate clinical benefit for CCA patients with high unmet medical needs and are looking forward to the progress in FIRST-308 study to bring the novel therapy to CCA patients.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is