Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...
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Delivering Immunotherapeutics Intratumorally: Safe for Treating Cancer?

Intravenous administration of chemotherapy is the conventional method of delivery. However, several issues arise with this method, including insufficient drug penetration into the tumor tissue. Intratumoral injections of immunotherapies directly into the tumor have been a possible solution to this problem, and, according to a recent study, results of which are published in JAMA Network Open, this technique has been found to be a viable option for a variety of histological conditions and target o...
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First CAR T-Cell Therapy Approved for Mantle Cell Lymphoma

The FDA has now granted accelerated approval to brexucabtagene autoleucel (TecartusTM, Kite Pharma, formerly known as KTE-X19) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, is the first CAR T-cell therapy approved for this rare type of B-cell non-Hodgkin lymphoma. Efficacy was evaluated in the multicenter, open-label phase 2 ZUMA-2 trial (NCT02601313), which enrolled 7...
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Advanced Melanoma: Pembrolizumab Effective Regardless of BRAF V600E/K Mutations

In patients with advanced melanoma, pembrolizumab achieves efficacy regardless of BRAF V600E/K mutation status or prior treatment with BRAF and/or MEK inhibitors, according to the results of a new pooled analysis published in JAMA Oncology. Approximately 40% of metastatic melanomas harbor a BRAF mutation, 90% of which are an activating BRAF V600E/K mutation. While targeted agents and immune checkpoint inhibitors, including pembrolizumab, have considerably improved outcomes for patients with adva...
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FDA Approves First-Line Pembrolizumab: Metastatic MSI-High/dMMR Colorectal Cancer

Patients with unresectable or metastatic colorectal cancer with high microsatellite instability (MSI) or a deficiency in mismatch repair (dMMR) now have their first frontline immunotherapy option, thanks to the FDA's approval of pembrolizumab (Keytruda®, Merck) in this population. Efficacy and safety were investigated in an open-label phase 3 trial, KEYNOTE-177 (NCT02563002), for which 307 patients with previously untreated MSI-high/dMMR metastatic colorectal cancer and an Eastern Cooperative On...
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