Kristi Rosa

Articles

FDA Approves Nivolumab Plus Cabozantinib for Advanced RCC

January 22nd 2021

January 22, 2021 - The FDA has approved the combination of nivolumab plus cabozantinib for the frontline treatment of patients with advanced renal cell carcinoma.

Axicabtagene Ciloleucel Approved in Japan for Relapsed/Refractory LBCL

January 22nd 2021

January 22, 2021 — The Japan Ministry of Health, Labour and Welfare has approved the CAR T-cell therapy axicabtagene ciloleucel for use in the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas.

FDA Grants Priority Review to Retifanlimab for Squamous Cell Carcinoma of the Anal Canal

January 21st 2021

January 21, 2021 - The FDA has granted priority review to a biologics license application for retifanlimab for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who were intolerant of or who had progressed on platinum-based chemotherapy.

Trastuzumab Deruxtecan Approved in Europe for HER2+ Metastatic Breast Cancer

January 20th 2021

January 20, 2021 - The antibody-drug conjugate trastuzumab deruxtecan has been granted conditional approval in the European Union for use as a single agent in the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received 2 or more HER2-based regimens.

FDA Grants Priority Review to Adjuvant Nivolumab for Resected Esophageal or GEJ Cancer

January 20th 2021

The FDA has granted priority review to a supplemental biologics license application for nivolumab for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation treatment.

FDA Grants Priority Review to Nivolumab/Chemo for Frontline Metastatic Gastric, GEJ, and Esophageal Cancer

January 20th 2021

January 20, 2021 - The FDA has granted a priority review to a supplemental biologics license application for nivolumab in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

FDA Grants Premarket Approval to Diagnostic Breast Cancer Imaging Technology

January 19th 2021

January 19, 2021 - The FDA’s Center for Devices and Radiological Health has granted premarket approval to diagnostic breast cancer imaging technology developed by Seno Medical Instruments to assist in the differentiation between benign and malignant breast lesions in patients.

FDA Grants Priority Review to Narsoplimab for HSCT-TMA

January 19th 2021

January 19, 2021 — The FDA has granted priority review to the biologics license application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

FDA Grants Fast Track Status to Padeliporfin ImPACT for Upper-Tract Urothelial Cancer

January 18th 2021

January 18, 2021 — The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer.

Infigratinib Shows Promising Anticancer Activity in Chemo-Refractory, FGFR2+ Cholangiocarcinoma

January 17th 2021

January 17, 2021 - Infigratinib was found to be associated with encouraging clinical activity with a manageable safety profile in patients with chemotherapy-refractory cholangiocarcinoma whose tumors harbor FGFR2 fusions.

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