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FDA News Briefs for Monday, May 6, 2019

May 6, 2019

These Food and Drug Administration (FDA) developments came in last week:


FDA Approves First Treatments for ATTR-CM

The FDA has approved 2 capsules, Vyndaqel and Vyndamax (tafamidis meglumine and tafamidis; Pfizer), for the treatment of adult patients with cardiomyopathy caused by transthyretin mediated amyloidosis (ATTR-CM). ATTR-CM is a rare and life-threatening disease caused by the buildup of abnormal deposits of amyloid in the organs and tissues. Both drugs contain the same active moiety (tafamidis), but the recommended doses differ between the drugs. More Information.


FDA Expands Indications for Kadcyla

The FDA has approved a supplemental biologics license application for Kadcyla (ado-trastuzumab emtansine; Genentech). Kadcyla is an HER2-targeted antibody and microtubule inhibitor conjugate indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)-based treatment. It is administered via intravenous infusion every 3 weeks (21-day cycle) until disease progression, unacceptable toxicity, or a total of 14 cycles are given. More Information.