CHMP Positive Opinion for Sugemalimab in Stage III NSCLC
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, remarked, “We are encouraged that the EMA review for our Stage III NSCLC indication has progressed so rapidly and positively. Coming just one year after sugemalimab’s first approval in Europe for first-line metastatic squamous and non-squamous NSCLC in 2024, this marks the second positive opinion and recommendation from CHMP. If approved, sugemalimab’s role as a core immunotherapy for lung cancer will be further solidified, significantly enhancing its market presence and commercial potential. We will work closely with our partners to expedite the full commercialization of sugemalimab across European markets, making this high-quality and accessible treatment option available to more patients.”
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines