NMPA grants Tislelizumab + chemo approval for 1L use in advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression
“Advanced gastric cancer remains a significant cause of cancer-related mortality in China and we are pleased that tislelizumab plus chemotherapy demonstrated a meaningful survival benefit for patients whose tumors express PD-L1 in the RATIONALE 305 study,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We are grateful to the patients, investigators, and experts from across the world who took part in the RATIONALE 305 trial and look forward to bringing another immunotherapy-based treatment option to patients in China.”
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
