Nivolumab Gains First Indication in China for NSCLC
June 20th 2018Last week, Bristol-Myers Squibb announced that the China National Drug Administration approved the country’s first immuno-oncology and first PD-1 therapy, nivolumab (Opdivo), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
CD22 CAR T-cell Therapy Effective After CD19 CAR Therapy Failure in Children With B-ALL
June 16th 2018A CAR T-cell therapy specific for CD22 was safe and provided high response rates for pediatric patients with B-cell acute lymphoblastic leukemia who had failed chemotherapy and/or a CD19-targeted CAR T-cell treatment.
RA Drug May Reduce Toxicity Caused By CAR T Treatment
June 15th 2018Last year, the FDA expanded the indications of rheumatoid arthritis (RA) drug tocilizumab (Actemra) to include the treatment of cytokine release syndrome (CRS) caused by CAR T-cell therapy. Recently, 2 studies have identified another rheumatoid arthritis drug that could be more effective in the treatment of CRS.
FDA Approves Pembrolizumab for Relapsed/Refractory PMBCL
June 13th 2018The FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or those who have relapsed after 2 or more prior lines of therapy.
Gilteritinib Proves Promising for the Treatment of FLT3mut + Acute Myeloid Leukemia
June 8th 2018Planned analyses of phase 3 trial of gilteritinib as a maintenance therapy after allogeneic hematopoietic stem cell transplantation in patients with Fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations in acute myeloid leukemia (AML).
FDA Grants Breakthrough Therapy Designation to Gene Therapy for Cerebral Adrenoleukodystrophy
June 3rd 2018The FDA has granted a Breakthrough Therapy designation to bluebird bio, Inc’s Lenti-D, a gene therapy for patients with cerebral adrenoleukodystrophy, an X-linked genetic disorder caused by a defect in the gene ABCD1.
Promising Early Phase Results With bb2121 CAR T Treatment in Relapsed Refractory Multiple Myeloma
June 2nd 2018At the 2018 American Society of Clinical Oncology Annual Meeting, June 1-5, Chicago, Illinois, Noopur S. Raje, MD, director, Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, presented results from the phase 1 multicenter study with a second-generation chimeric antigen receptor (CAR) T-cell therapy called bb2121.
FDA Grants Crizotinib Breakthrough Designation for MET+ NSCLC and ALK+ ALCL
May 30th 2018The FDA has granted crizotinib a breakthrough therapy designation for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations, and for use in patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.