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.