May 7th 2024
For antibody drug conjugates to reach their full potential, developers should focus on addressing current challenges such as safety and efficacy.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
March 19th 2024Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Artificial Intelligence Drives Industry Response to Project Optimus
February 27th 2024The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.
FDA Approves New Biweekly Reduced Dosing of Tecvayli Based on Phase I/II MajesTEC-1 Trial Data
February 21st 2024The Phase I/II MajesTEC-1 trial (NCT03145181; NCT04557098) evaluated Tecvayli (teclistamab-cqyv) at a reduced dose of 1.5 mg/kg administered every two weeks in patients with relapsed/refractory multiple myeloma.
Phase III INDIGO Trial Data Lead to FDA Priority Review for Vorasidenib in IDH-Mutant Gliomas
February 20th 2024Data from the pivotal, global, randomized, double-blind, placebo-controlled, Phase III INDIGO trial show statistically significant and clinically meaningful progression-free survival for vorasidenib treating IDH-mutant gliomas.
FDA Upgrades Tepmetko to Full Approval for Metastatic NSCLC Based on VISION Trial Data
February 16th 2024Single-arm, open-label, multicenter, non-randomized, multicohort Phase II VISION trial (NCT02864992) of Tepmetko (tepotinib) for metastatic non–small cell lung cancer shows favorable objective response rate.