New FDA Specialty Approvals

April 6: The FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people with K-ras wild-type epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The previously approved 250 mg/m2 per-week regimen remains an option. The drug’s monthly list price is $13,596.20. Visit www.erbitux.com.

April 7: The FDA gave full approval to Gilead Sciences, Inc.’s Trodelvy (sacituzumab govitecan- hziy) for adults with unresectable locally advanced or metastatic triple- negative breast cancer who have received at least two systemic therapies, including at least one for metastatic disease. The agency gave the antibody-drug conjugate accelerated approval on April 22, 2020 (RSP 5/20, p. 8). The recommended dose of the intravenous infusion is 10 mg/kg once weekly on days one and eight of a continuous 21-day treatment cycle. Dosing for the first infusion is over three hours, which can be reduced to one to two hours if that dosing is tolerated. Website Drugs.com lists the price of one single-dose vial of 180 mg lyophilized powder as more than $2,173. Visit https://trodelvy.com.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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