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Food and Drug Administration (FDA) has approved Kadcyla[R] (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin[R] (trastuzumab)-based treatment.
[Fam-] trastuzumab deruxtecan is in pivotal phase 3 development in previously treated HER2 low expressing metastatic breast cancer versus investigator's choice (DESTINY-Breast04); phase 3 development in HER2 positive metastatic breast cancer versus ado-trastuzumab emtansine (T-DM1) (DESTINY-Breast03); and phase 3 development in HER2 positive metastatic breast cancer versus investigator's choice post T-DM1 (DESTINY-Breast02).
All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine. The combination of margetuximab and chemotherapy demonstrated acceptable safety and tolerability, comparable overall to that of trastuzumab and chemotherapy.
- US-based biotechnology company Genentech, a member of Switzerland's Roche Group (SIX: ROG) (OTCQX: RHHBY), has completed the submission of a supplemental Biologics License Application to the US Food and Drug Administration for Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant (before surgery) treatment, the company said.
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine or T-DM1) have led to improved time to progression and survival rates of HER2+ patients.
Preliminary overall efficacy results in 20 evaluable patients demonstrated an objective response rate of 35% (seven partial responses) and disease control rate of 90%, including 12 patients previously treated with ado-trastuzumab emtansine (T-DM1) and five patients with HER2 low expression (IHC2+/FISH- or IHC1+).
The global breast cancer therapeutics market report estimates the market size (Revenue USD million - 2013 to 2020) for key market segments based on the drug classes - brand name (chemical name) such as antimetabolites - Gemzar (gemcitabine), aromatase inhibitors - Afinitor (everolimus), Arimidex (anastrozole), Aromasin (exemestane), Femara (leterozole), Ibrance (palbociclib); Her2 Inhibitors - Herceptin (trastuzumab), Kadcyla (ado-trastuzumab emtansine), Perjeta (pertuzumab), Tykerb (lapatinib); Hormone receptors - Fareston, Faslodex, Zoladex; and Mitotic inhibitors - Halaven (eribulin), Ixempra (ixabepilone), Taxotere (docetaxel), and forecasts growth trends (CAGR% - 2016 to 2020).
Ado-Trastuzumab Emtansine. Ado-trastuzumab emtansine is an antibody-drug conjugate consisting of the monoclonal antibody trastuzumab linked to the cytotoxic agent mertansine (DM1).
Kadcyla, which is manufactured by a subsidiary of the Roche group, is properly known as ado-trastuzumab emtansine. This is similar to another Roche drug, the breast cancer therapy Herceptin, which is generically known as trastuzumab.
The US Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.