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# Review Period Set for Kadcyla
- URL: https://www.fdaweb.com/review-period-set-for-kadcyla/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:23:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134307

*Federal Register* Notice: FDA has determined the regulatory review period for Genentech’s Kadcyla (ado-trastuzumab emtansine) for extending a patent which claims the human biological product. Kadcyla is indicated as a single agent, for treating patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2015-12-28/pdf/2015-32475.pdf?ref=fdaweb.com).