FDA Issues Complete Response Letter for Glofitamab in R/R DLBCL Combination Therapy
FDA issues a complete response letter for glofitamab’s second-line DLBCL indication, highlighting ongoing scrutiny in oncology therapy approvals.
Related Articles
FDA Issues CRL for RP1 in Advanced Melanoma
Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete response letter.
Linvoseltamab Plus Carfilzomib Shows Manageable Safety in RRMM
Rajshekhar Chakraborty, MD, discusses the safety and tolerability of linvoseltamab with carfilzomib when used for the treatment of patients with relapsed/refractory multiple myeloma.
Tailoring CLL Treatment with BTK Inhibitors in a Community Setting
During a live event, Andrew H. Lipsky, MD, and participants discussed balancing efficacy, safety, and patient preferences when choosing CLL treatment.
Osimertinib Plus Chemotherapy Significantly Extends Survival in Advanced EGFRm NSCLC
Osimertinib plus chemotherapy significantly improves overall survival in EGFRm NSCLC, signaling a new standard of care.
Real-World Applicability of BTKi Use and Comparative Outcomes
Panelist discusses how Bruton tyrosine kinase inhibitors fit into real-world practice with community physicians often using monotherapy, while emphasizing the importance of specialist knowledge to…
Dual Bispecific Therapy Shows Promise in High-Risk Multiple Myeloma With EMD
Shahzad Raza, MD, explains the rationale behind the REDIRECTT-1 study.
T-DXd Breakthrough Designation Signals New Era for HER2-Positive Metastatic Breast Cancer
FDA designates T-DXd plus pertuzumab as breakthrough therapy for HER2-positive metastatic breast cancer, promising improved survival rates for patients.
Newer Approaches Show Potential to Reduce Need for Transplant in NDMM
During a live event, Hans Lee, MD, and participants shared their perspectives on current and upcoming treatment approaches in transplant-eligible multiple myeloma.
Reshaping Treatment-Naive CLL: Emerging BTKi-Based Combination Strategies
Panelist discusses how new all-oral combination regimens are transforming the treatment landscape by addressing unmet needs in patients with high-risk chronic lymphocytic leukemia, particularly those…
Will Belantamab Mafodotin Get a Second Chance at Approval in Multiple Myeloma?
George Mulligan, PhD, previews the FDA’s ODAC meeting discussing the application of belantamab mafodotin-based combinations for the treatment of multiple myeloma.