FDA to Reassess Accelerated Immunotherapy Approvals
March 12th 2021Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.
Pembrolizumab-Ipilimumab Combo Boosts Toxicity, Not Survival in NSCLC
February 7th 2021Pembrolizumab (Keytruda) combined with ipilimumab (Yervoy) did not improve survival and had higher rates of toxicity compared with pembrolizumab monotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) who had a PD-L1 tumor proportion score (TPS) of 50% or greater, and did not harbor EGFR or ALK aberrations.
Immunotherapy May Highlight Neoadjuvant Treatment's Use in Lung Cancer
January 25th 2021The radiographic and pathologic responses that have been seen with checkpoint inhibitors in lung cancer bodes well for the use of neoadjuvant therapy. However, the relationship between response and long-term outcomes, specifically with regard to overall survival, will have to be teased out before they become standard practice, explained David Spigel, MD.
Nivolumab Plus Cabozantinib Gets Priority Review for Advanced RCC Treatment
October 20th 2020The FDA has granted a priority review designation to a supplemental biologics license application and supplemental new drug application for nivolumab (Opdivo) plus cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma.
Immunotherapy Combos in Advanced Nonsquamous NSCLC: What Does the Data Say?
September 29th 2020The paradigm of advanced nonsquamous non–small cell lung cancer (NSCLC) is now one that necessitates discussions regarding the use of combination chemoimmunotherapy, combination immunotherapy, and single-agent immunotherapy, explained Jonathan Dowell, MD.
Investigational CAR T-Cell Product Plus Immunotherapy Is Active in DLBCL
September 26th 2020The investigational CAR T-cell product AUTO3 in combination with pembrolizumab was found to have a tolerable safety profile and elicit durable complete responses in patients with relapsed/refractory diffuse large B-cell lymphoma.
Novel Molecule Enhances Immunotherapy Response in CRC, According to Early Data
September 19th 2020The advent of immunotherapy has revolutionized multiple areas of cancer treatment, said Timothy Cragin Wang, MD, who added that the transformative potential of the modality has been mild at best in the field of colorectal cancer (CRC).