The FDA accepted a supplemental biologics license application and granted a priority review to durvalumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer.
Kristie L. Kahl
The FDA has granted a priority review to a new drug application for pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
Research on chimeric antigen receptor T-cell therapy to be presented at the ASH Annual Meeting & Exposition is set to address drawbacks associated with treatment.
Robert A. Brodsky, MD discussed the study of a first-of-kind multi-antigen targeted off-the-shelf chimeric antigen receptor- natural killer cell therapy with engineered persistence that will be presented at the ASH Annual Meeting & Exposition.
As part of Project Orbis, The FDA has approved acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA granted accelerated approval to zanubrutinib for the treatment of adult patients with MCL who have received at least 1 prior therapy.
Overcoming resistance and determining better treatment plans that address the underlying disease biology of mantle cell lymphoma.
Researchers have opened an expansion cohort to include patients with mantle cell lymphoma in the phase I/II CIRLL study to determine if adding cirmtuzumab to ibrutinib can increase the rate of complete remissions.
The FDA has accepted the supplemental biologics license application and granted breakthrough therapy designation to nivolumab plus ipilimumab for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.
Treatment with trastuzumab emtansine demonstrated similar overall survival across 3 treatment arms of patients with HER2‐positive metastatic breast cancer.