Trilaciclib Approved for Chemotherapy-Induced Myelosuppression
The U.S. Food and Drug Administration (FDA) has approved trilaciclib, a cyclin-dependent kinase 4/6 inhibitor, to reduce the frequency of bone marrow suppression in...
Axicabtagene Ciloleucel Approved for Relapsed/Refractory Follicular Lymphoma
The FDA has approved axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory indolent follicular lymphoma (FL) who have received two...
FDA Grants Breakthrough Therapy Designation to Asciminib for CML
The FDA has granted breakthrough therapy designation to asciminib, a first-in-class allosteric inhibitor specifically targeting the ABL myristoyl pocket (STAMP), for the treatment of...
Melphalan Flufenamide Receives Accelerated Approval for Relapsed/Refractory Multiple Myeloma
Melphalan flufenamide, in combination with dexamethasone, has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory multiple...
FDA Accepts sNDA for Zanubrutinib in Waldenström Macroglobulinemia
The FDA has accepted a supplemental new drug application (sNDA) for zanubrutinib for the treatment of adults with Waldenström macroglobulinemia (WM).
The sNDA, submitted by...
Crizotinib Approved for Relapsed/Refractory Systemic ALCL
Crizotinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children older than one year and young adults...
Daratumumab and Hyaluronidase-fihj Approved for Light Chain Amyloidosis
The combination of daratumumab and hyaluronidase-fihj and bortezomib, cyclophosphamide, and dexamethasone (D-VCd) was granted accelerated approval for the treatment of adults with newly diagnosed...
FDA Accepts IND Application for PBCAR19B
The FDA cleared Precision BioSciences’ Investigational New Drug (IND) application for its chimeric antigen receptor (CAR) T-cell therapy PBCAR19B. The company will initiate a...
IND Application Cleared for VOR33 in CD33+ Acute Myeloid Leukemia
The FDA cleared Vor Biopharma’s IND application for its hematopoietic cell therapy VOR33. This decision allows the company to initiate a phase I/IIa clinical...
VLX-1005 Receives Orphan Drug Designation
The FDA granted orphan drug designation to VLX-1005 as thrombosis prophylaxis in patients with heparin-induced thrombocytopenia (HIT).
According to its manufacturer, Veralox Therapeutics, preclinical data...
Current Issue
April 2021 Volume 7 Issue 5
This issue examines long-haul COVID-19, central nervous system relapse in non-Hodgkin lymphoma, and more.