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Nov. 2020 News Update

Updated: Nov 14


Pembrolizumab (Keytruda) and chemotherapy was FDA-approved in Nov. 2020 based upon the KEYNOTE-355 trial which randomized TNBC MBC patients who had not previously taken chemotherapy in the metastatic setting to receive either Keytruda plus chemotherapy or chemotherapy alone. The median PFS was 9.7 months for patients taking the combination vs. 5.6 months for patients taking chemotherapy only.


A test called PD-L1 IHC 22C3 pharmDx has been FDA-approved as a companion diagnostic for selecting patients with TNBC to be eligible for the Keytruda plus chemotherapy regimen. From: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-locally-recurrent-unresectable-or-metastatic-triple

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