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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.
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.
Positive Results Correlate With Use of Darolutamide in nmCRPC
February 10th 2022In an interview with Targeted Oncology, Neal Shore discusses the findings of ARAMIS which looked at darolutamide in men with high-risk non-metastatic castration-resistant prostate cancer, and its primary end point of metastasis-free survival.
KEYNOTE-522 Shows Prolonged EFS With Adjuvant Pembrolizumab in High-Risk, Early-Stage TNBC
February 10th 2022In KEYNOTE-522, treatment with adjuvant pembrolizumab following neoadjuvant pembrolizumab with chemotherapy showed a statistically significant prolonged event-free survival in patients with high-risk early-stage triple-negative breast cancer.