April 29th 2024
Enhertu, a HER2-directed antibody-drug conjugate, showed a clinically meaningful survival benefit in progression-free survival among patients with HR-positive, HER2-low metastatic breast cancer.
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.