FDA Approves Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC

On November 13, 2020, the FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (as determined by an FDA test) based on progression-free survival (PFS).

The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx, on this date.

This approval was based on data from the KEYNOTE-355 trial, a multicenter-double-blind, randomized, placebo-controlled trial, where patients who had not been previously treated with chemotherapy in a metastatic setting were randomized in a 2:1 ratio to receive pembrolizumab or placebo in combination with different chemotherapy treatments (paclitaxel, paclitaxel-protein bound, or gemcitabine plus carboplatin).

The main end point was PFS, independently reviewed according to RECIST 1.1. In the pembrolizumab plus chemotherapy arm, median PFS was 9.7 months (95%CI, 7.6-11.3) versus 5.6 months (95% CI, 5.3-7.5) in the placebo arm.

The most common (≥20%) adverse reactions associated with pembrolizumab treatment were fatigue, nausea, diarrhea, constipation, vomiting, alopecia, rash, cough, decreased appetite and headache.—Kaitlyn Manasterski

Source: US Food and Drug Administration. FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer November 13, 2020. Accessed November 13, 2020.

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