Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval of Enhertu represents the first HER2-directed therapy approved in China for the treatment of HER2-mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. It also reinforces the importance of testing for predictive biomarkers in lung cancer at the time of diagnosis, including HER2 mutations, to ensure patients can receive the most appropriate treatment for their specific disease.”
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
