FDA Grants Priority Review to Liso-Cel for Adults With Relapsed/Refractory LBCL
February 17th 2022The FDA will conduct a speedy review of the supplemental biologics license application for lisocabtagene maraleucel as second-line treatment for adult patients with relapsed or refractory large B-cell lymphoma.
ODAC Member Disagrees With Outcome for Sintilimab/Chemotherapy in Nonsquamous NSCLC
February 16th 2022In an interview with Targeted Oncology, Jorge Nieva, MD, provided a recap of the recent ODAC meeting and explained his stance against further research for frontline sintilimab plus chemotherapy for the treatment of patients with nonsquamous NSCLC.
Gene Therapy Shows Encouraging Clinical Efficacy/Safety in BCG-Unresponsive NMIBC
February 11th 2022A novel gene therapy is being investigated for the treatment of Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer, and the preliminary findings signal a high response rate with little toxicity.
FDA’s ODAC Votes No to Approval of Frontline Sintilimab/Chemotherapy in Nonsquamous NSCLC
February 10th 2022The FDA’s Oncologic Drug Advisory Committee has voted against approval of the biologics license application for sintilimab plus pemetrexed and platinum-based chemotherapy for the treatment of nonsquamous non–small cell lung cancer without further clinical trial research.
Phase 2B Study Explores I/O Vaccine for Treatment of Newly Diagnosed Glioblastoma Patients
February 8th 2022After treatment with SurVaxM in patients with newly diagnosed glioblastoma significantly improved survival, investigators are continuing the evaluation of the agent in a phase 2b clinical trial.
FDA Grants Breakthrough Therapy Designation to DZD9008 for EGFR Exon20Ins-Positive NSCLC
January 27th 2022DZD9008 for the treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring with EGFR exon20 insertion mutations is an investigative treatment strategy in a clinical trial.
FDA Approves Tebentafusp-tebn in Adult HLA-A*02:01-Positive Unresectable/Metastatic Uveal Melanoma
January 26th 2022Tebentafusp-tebn has been granted FDA approval to treat HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma based on positive results from a phase 3 study.
Ripretinib Stills Holds a Place in the Advanced GIST Landscape After INTRIGUE Study
January 25th 2022Results presented during the 2022 January ASCO Plenary Series showed that ripretinib did perform better than sunitinib in terms of the objective response rate, and the safety profile of the drug was favorable compared with sunitinib.