FDA grants accelerated approval to HYRNUO™ (sevabertinib) for patients with previously treated advanced HER2-mutant NSCLC
“Globally, it is estimated that up to 84,000 people are diagnosed with NSCLC harboring a HER2 mutation each year,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “At Bayer our oncology R&D strategy is centered on precision drug development which is designed to help us address critical unmet medical needs through the advancement of innovative therapies. Today’s FDA approval of sevabertinib exemplifies this approach, delivering a targeted treatment specifically for patients with advanced HER2-mutant NSCLC. This significant milestone underscores our unwavering commitment to transforming cancer care by delivering meaningful therapies that have the potential to improve outcomes and extend survival for people living with cancer.”
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us