The American Journal of Managed Care1d
After ODAC, What’s Next for MRD Testing in Multiple Myeloma?
April's vote of the FDA Oncology Drug Advisory Committee to support use of MRD-negative CR as an end point for accelerated ...
The American Journal of Managed Care1h
CEPHEUS: Sub-Q Daratumumab With VRd Improves MRD Negativity, PFS in Myeloma if Transplant Deferred
The trial is seen as a complement to the MAIA trial, which had shown a significant overall survival benefit with daratumumab ...
FiercePharma1d
UPDATED: Experts support FDA's plan for restrictions on PD-1 drugs in stomach, esophageal cancers
The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered.  | The days of broad stomach cancer labels ...
Targeted Oncology1d
FDA ODAC Votes Against Checkpoint Inhibitors in PD–L1-Negative Esophageal Cancer
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in esophageal cancer with PD-L1 ...
Targeted Oncology1d
FDA ODAC Finds Limited Benefit for Checkpoint Inhibitors in Low PD-L1 Gastric Cancer
The FDA’s Oncologic Drug Advisory Committee voted against the use of checkpoint inhibitors in first-line advanced gastric ...
MedPage Today3h
No Benefit for PD-1 Inhibitors in Certain Gastroesophageal Cancers, FDA Panel Says
By way of two resoundingly consistent votes, members of an FDA advisory committee agreed that PD-1 inhibitors do not have a favorable risk/benefit profile for gastroesophageal cancers with low PD-L1 ...
precisionmedicineonline1h
FDA Panel Finds Limited Immunotherapy Benefit in PD-L1-Negative Gastric, Esophageal Cancer
The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
MedPage Today3d
Immunotherapy May Not Benefit All Gastroesophageal Cancer Patients, FDA Staff Says
"If patients with low or no PD-L1 expression are not expected to benefit based on the available data, then administering anti ...
BioWorld1d
ODAC expresses itself on PD-L1, checkpoint inhibitors
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors ...
The Franklin News Post1d
Ferrum women’s soccer remain undefeated through eight games; begin ODAC play on Saturday
The Ferrum Women’s soccer team is now 8-0 to open the 2024 season, the best start in program history. The Panther women’s ...
WFXR Roanoke on MSN1d
Chesapeake Challenge comes to Salem Stadium
Landmark Conference and Old Dominion Athletic Conference (ODAC) football fans enjoyed two additional games in 2023 with the ...
Medscape3d
FDA Highlights Concerns Over International Cancer Trials in Draft Guidance
In a proposed guidance, the FDA voiced concerns over whether cancer clinical trials largely or entirely conducted outside the ...