FDA Grants Breakthrough Designation to JNJ-6372 for EGFR Exon 20-Mutant NSCLC
March 11th 2020The FDA has granted a breakthrough therapy designation to JNJ-61186372 for the treatment of patients with EGFR-positive metastatic non–small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy.
Ixazomib Frontline Triplet Misses PFS Endpoint in Transplant-Ineligible Myeloma
March 10th 2020The triplet therapy of ixazomib, lenalidomide, and dexamethasone showed an improvement in progression-free survival, but it was not statistically significant, compared with lenalidomide/dexamethasone alone for patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplant.
Innovation and Novel Therapies
March 3rd 2020During a discussion at The American Journal of Managed Care®’s Patient- Centered Oncology Care® meeting in Philadelphia, panelists outlined the efficacy of the 2 FDA-approved therapies, Medicare reimbursement for CAR T-cell therapies, and the pace of innovation in healthcare.
Key AE Management Strategies in Place for CAR T-Cell Therapy in Hematologic Cancers
February 29th 2020With the main toxicities associated with CAR T-cell therapy being cytokine release syndrome and neurotoxicity, a multidisciplinary approach is vital to providing inclusive care to patients receiving this type of treatment.
FDA Grants Breakthrough Designation to Debio 1143 in Frontline Head and Neck Cancer
February 27th 2020The FDA has granted a breakthrough therapy designation to Debio 1143, an inhibitor of apoptosis protein antagonist, for the treatment of patients with previously untreated, unresectable, locally advanced squamous cell carcinoma of the head and neck in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy
CAR T-Cell Therapy Improves Health-Related QOL in Adult Patients With R/R DLBCL
February 26th 2020Health-related quality of life (QOL) improved in 54% of patients 18 years or older with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) after therapy with tisagenlecleucel (Kymriah; Novartis), one of 2 FDA-approved chimeric antigen receptor (CAR) T-cell therapies. The patients’ general health, vitality, physical function, and social function improved the most.
"Off-the-Shelf" CAR T-Cell Therapy Shows Promise in Non-Hodgkin Lymphoma
February 22nd 2020An “off-the-shelf” Epstein Barr-virus–specific cytotoxic lymphocyte CAR product derived from cells harvested from third-party donors induced a 100% response rate in adult and pediatric patients with relapsed/refractory non-Hodgkin lymphoma.
Andrew J. Cowan, MD, Discusses the Phase I Clinical Trial of GSI and BCMA CAR T-Cells
February 17th 2020The expert explained the rationale for the phase I first-in-human clinical trial evaluating the combination of a gamma-secretase inhibitor and B-cell maturation antigen CAR T-cells in patients with heavily pretreated multiple myeloma.
CD19-Directed CAR-NK Cell Therapy Elicits Responses in Non-Hodgkin Lymphoma and CLL
February 13th 2020Treatment with a CD19-targeted CAR-natural killer–cell therapy led to a 73% objective response rate, including 7 complete responses, in patients with relapsed/refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia.
FDA Grants Priority Review to Liso-Cel in Large B-Cell Lymphoma
February 13th 2020The FDA has granted a priority review designation to a biologics license application for the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.
CTC Detection Linked to Relapse in Stage III Melanoma
February 12th 2020The presence of circulating tumor cell was found to be independently associated with relapse in patients with stage III melanoma, suggesting that CTC assessment may be useful in identify patients who are at risk for relapse and could benefit from adjuvant therapy.