FDA Accepts BLA for Ivonescimab + Chemo in EGFRm NSCLC Post-TKI Therapy; PDUFA Nov 2026
“This NDA reaffirms Elevar’s mission of bringing life-changing medicines to cancer patients worldwide, including for rare indications and for advanced stages where treatment options are limited,” said Dong-Gun Kim, the company’s chief executive officer. “We are excited to work with the FDA as it reviews the submission while simultaneously preparing for a potential commercial launch. We could not be more appreciative of the patients who participated in lirafugratinib-focused clinical trials and everyone who brought us to this crucial point in its development.”
Share:
More News
Dr. Michael Ge, CEO of Kelun-Biotech said, “We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA® as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit
“We are excited to work with Merck to advance this promising investigational combination in RAS-driven cancers,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “RAS mutations activate the RAS/MAPK pathway and promote an immunosuppressive environment. Non-clinical data suggest that targeting the pathway with ERAS-0015 may complement PD-1 blockade
“Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer,” said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. “With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and
“The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month