Posts by: Patricia Inacio, PhD

News

The U.S. Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients. Granted under priority ... Read more

November 9, 2020November 9, 2020

Opdivo-Yervoy-Chemo Combo Approved in EU for Advanced NSCLC

News

The European Commission has approved a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) plus two cycles of platinum-based chemotherapy as a first-line treatment for people with advanced non-small cell lung cancer ... Read more

October 26, 2020October 27, 2020

Opdivo-Cabometyx Granted FDA Priority Review for Newly Diagnosed Advanced Kidney Cancer

News

The U.S. Food and Drug Administration (FDA) has agreed to review applications requesting the approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for people with advanced renal cell cancer, the most common type ... Read more

October 21, 2020October 21, 2020

Committee Recommends EU Approval of Opdivo to Treat Advanced Esophageal Cancer

News

A committee of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of people with advanced, inoperable, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) ... Read more

October 19, 2020October 19, 2020

Tecartus Recommended for EU Approval as CAR T-cell Therapy for Mantle Cell Lymphoma

News

A committee of the European Medicines Agency (EMA) has recommended the conditional approval of Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). The ... Read more

October 16, 2020October 16, 2020

FDA Approves Keytruda for Adults as Second-Line Therapy for Hodgkin’s Lymphoma

News

The U.S. Food and Drug Administration (FDA) has expanded the use of Keytruda (pembrolizumab) as a second-line treatment for adults with relapsed or refractory classical Hodgkin’s lymphoma (cHL) for whom initial ... Read more

September 18, 2020September 18, 2020

EMA to Review Opdivo-Yervoy Combo for Untreated, Inoperable Mesothelioma

News

The European Medicines Agency has agreed to review Bristol Myers Squibb’s application requesting approval for the dual immunotherapy regimen Opdivo (nivolumab) and Yervoy (ipilimumab) for untreated, inoperable malignant pleural mesothelioma (MPM). This ... Read more

June 26, 2020June 26, 2020

FDA Approves Keytruda for Advanced Squamous Cell Skin Cancer

News

The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as a treatment for people with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) — the second most common ... Read more

June 15, 2020June 15, 2020

Cancer Vaccine Plus Adoptive T-cell Therapy Placed on Fast Track

News

TVI-Brain-1, an immunotherapy being developed by TVAX Biomedical, was given fast track designation by the U.S. Food and Drug Administration (FDA) as a potential treatment of glioblastoma multiforme, a deadly form ... Read more

May 12, 2020May 12, 2020

ICT’s CAR T-cell Therapy Shows Promise in Reducing Size of Solid Tumors

News

A potential CAR T-cell therapy by Innovative Cellular Therapeutics (ICT) showed early signs of safety and efficacy, significantly reducing tumor size in four patients with thyroid or colorectal cancer, new ... Read more