To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
FDA approved Welireg (belzutifan) for patients with advanced renal cell carcinoma following a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor.
FDA approved Iwilfin (eflornithine) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
NIH and FDA envision transforming the way clinical trials are done across the biomedical research enterprise.
FDA approved Jaypirca (pirtobrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
FDA granted Fast Track Designation for Alpha1H for the treatment of non-muscle invasive bladder cancer. Alpha1H is sponsored by Hamlet BioPharma AB.
FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies.
FDA approved Xtandi (enzalutamide) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma.
Invoking the Defense Production Act, President Joe Biden has ordered federal agencies and artificial intelligence companies to create safeguards and standards for the technology that has the capacity to uplift humankind as much as it can wreak unimaginable harm.
