FDA has approved PD-L1 IHC 22C3 pharmDx, Code SK006m as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.
ImmunityBio and its owner and executive chairman Patrick Soon-Shiong received a warning letter from FDA for making false and misleading claims about a cancer treatment in television ads and on a podcast.
