At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.
On June 17, the FDA approved checkpoint blocker Keytruda (pembrolizumab, Merck & Co. Inc.) “for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.”
Hayward, Calif.-based Reflexion Medical Inc. reported a clinical collaboration with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the safety and efficacy of Keytruda (pembrolizumab) in combination with biology-guided radiotherapy (BgRT) in multiple late-stage cancers. The goal is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment (EBRT) modality in development, is safe and amplifies Keytruda’s therapeutic effect.
The largest study to date on hypermutated gliomas has delivered new insights into their origin, as well as their response to several different treatments. Specifically, even though they are hypermutated, such tumors are unlikely to respond to PD-1 blockers.
The largest study to date on hypermutated gliomas has delivered new insights into their origin, as well as their response to several different treatments. Specifically, even though they are hypermutated, such tumors are unlikely to respond to PD-1 blockers.
PERTH, Australia – Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab).
PERTH, Australia – Sydney-based Immutep Ltd. reported positive interim data for its phase II basket trial in non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma for its lead immunotherapy in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab).
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy. Specifically, the assay will be used during the trial to analyze genomic markers to direct patient enrollment and stratification.
The U.S. FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics Inc.’s (PGDx) elio tissue complete assay in a Merck & Co. Inc. trial of a Keytruda (pembrolizumab)-based combination therapy.
PERTH, Australia – Australia is at risk of falling behind the U.S. and Europe in preventing recurrence of melanoma, the Melanoma Institute Australia warns. It is urging the Australian government to undertake a timely review of immunotherapy treatments effective in preventing the spread of melanoma and to fast track listings on the government-subsidized Pharmaceutical Benefits Scheme (PBS).
