Priority Review for Abatacept BLA Granted by the FDA for GVHD Prophylaxis
August 23rd 2021Priority review for a biologics license application for prophylactic abatacept has been granted by the FDA to help prevent the occurrence of severe graft-versus-host disease for patients undergoing hematopoietic stem cell transplant from an unrelated donor.
FDA Grants Fast Track Designation to STRO-002 in Select Patients With Advanced Ovarian Cancer
August 18th 2021The folate receptor α–targeting antibody-drug conjugate STRO-002 has a fast track designation from the FDA for advanced, platinum-resistant ovarian cancer following 1 to 3 prior lines of therapy.
Dostarlimab Gains New FDA-Approved Indication for Treatment of Mismatch Repair–Deficient Tumors
August 17th 2021Solid tumors with mismatch repair deficiency that have progressed on or after prior treatment and which have no suitable alternative therapy options may now be treated with dostarlimab following its approval by the FDA.