Top stories in hematology/oncology: CRISPR-edited T cells safe in patients with cancer, FDA grants another priority review to Keytruda

A study presented at the American Society of Hematology’s Meeting and Exposition found that cells genetically edited using CRISPR/Cas9 technology and infused back into patients with multiple myeloma and sarcoma appeared safe and feasible. This was among the week’s top stories in hematology/oncology.

News that the FDA granted priority review to Keytruda for certain patients with high-risk, nonmuscle-invasive bladder cancer was another top story.

CRISPR-edited T cells appear safe for patients with cancer

Immune cells genetically edited with CRISPR/Cas9 technology and infused back into patients with multiple myeloma and sarcoma appeared to be safe and represent a feasible therapeutic approach, according to results of a prospective phase 1 study presented at ASH Annual Meeting and Exposition. Read more.

FDA grants priority review to Keytruda for certain patients with high-risk bladder cancer

The FDA granted priority review to a supplemental biologics license application that seeks approval of pembrolizumab for treatment of certain patients with high-risk, nonmuscle-invasive bladder cancer. Read more.

Guest commentary: Most anticipated studies on chronic lymphocytic leukemia at ASH

Ryan W. Jacobs, MD, principal investigator of clinical trials for chronic lymphocytic leukemia at Atrium Health’s Levine Cancer Institute, reviews studies on CLL that were presented at the ASH Annual Meeting and Exposition. Read more.

FDA grants orphan drug designation to zotiraciclib for glioma

The FDA and European Medicines Agency granted orphan drug designation to zotiraciclib for the treatment of glioma, according to the agent’s manufacturer. Zotiraciclib (Adastra Pharmaceuticals) — a multikinase inhibitor — is being evaluated in two phase 1b clinical studies of patients with glioblastoma, the most common glioma histology. Read more.

FDA grants priority review to Imfinzi for lung cancer subset

The FDA granted priority review to a supplemental biologics license application that seeks approval of durvalumab for previously untreated extensive-stage small cell lung cancer. Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1. It is approved in the United States for treatment of patients with unresectable stage III non-small cell lung cancer, as well as for previously treated patients with advanced bladder cancer. Read more.