Keytruda Black Box Warning

[anonymous]

Cytokine storm reported in several rrMM patients with previous donor stem cell transplants. The recent recommendation from the independent data monitoring committee has the FDA looking for safety signals for all PD-1/PD-L1s in hematology. On the bright side, seems like the FDA doesn't think patients who already received a few doses should be worried. Meetings will continue with the FDA to determine labeling details. It's not clear if the company will be sharing this with the field at this point.

 

[anonymous]

Rumors of discussions with the FDA about a black box warning