Scemblix® Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML based on ASC4FIRST Ph 3 study data
“We welcome the FDA’s decision to grant Priority Review and Breakthrough Therapy designations to Scemblix for newly diagnosed CML patients, which underscores the substantial need for additional effective, safe and tolerable treatment options,” said Rodney Gillespie, Senior Vice President, Therapeutic Area Head, US Oncology, Novartis. “The ASC4FIRST data indicate that Scemblix, if approved, has the potential to address a critical gap in CML by offering a highly effective treatment along with a favorable safety and tolerability profile.”
Share:
More News
“We are honored to receive Orphan Drug Designation for PLT012, a milestone that reflects our dedication to addressing the urgent need for innovative therapies in liver and intrahepatic bile duct cancer,” said Dr. Raven Lin, CEO and Co-founder of Pilatus Biosciences. Prof. Ping-Chih Ho, Chair of the Scientific Advisory Board
“Immune checkpoint inhibitors play a vital role in the treatment of melanoma, yet patients who progress on or are intolerant to them have limited options,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Targeted therapies including MEK and RAF inhibitors have shown promise in melanoma but historically are severely
“This approval marks KEYTRUDA’s fourth lung cancer indication in China, embarking on a new journey of treating certain patients with earlier stage non-small cell lung cancer,” said Anna Van Acker, Senior Vice President of MSD and President of MSD in China. “KEYTRUDA has established an important role in immunotherapy for
“T-cell engagers targeting CD3 have successfully exploited the first signal in T-cell receptor signaling to treat liquid tumors, significantly expanding the treatment options for these cancers. However, solid tumors represent a much greater unmet clinical need that has yet to benefit from advances in immune-engaging bispecific antibodies,” said Nathan Trinklein,
