Comparative Safety of HER2 Antagonists Outlined

Advera Health Analytics has issued an evidence review on comparative safety of six HER2 antagonists indicated for treating breast and stomach cancers. The report (registration required) shows that based on FDA adverse event reporting data, Genentech’s Kadcyla (ado-trastuzumab emtansine) and Genentech’s Perjeta (pertuzumab) have multiple unlabeled adverse events that appear on Genentech’s Herceptin’s (trastuzumab) label. The report says these four events trigger Active RxSignals: Kadcyla and Perjeta for pulmonary fibrosis, Kadcyla for pulmonary hypertension and cardiac failure, and Perjeta for interstitial lung disease.

The agency adverse event data show that Kadcyla had the highest incidence rates for six out of seven patient outcomes, Advera says, and clinical trial data show Kadcyla had higher treatment rates than control rates for many serious adverse events.