New FDA Specialty Approvals
✦ May 29: The FDA expanded the label of Eli Lilly and Co.’s Cyramza (ramucirumab) to include, in combination with erlotinib, the first-line treatment of people with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 (L858R) mutations. Dosing is 10 mg/kg via intravenous infusion every two weeks with daily erlotinib. The monthly list price for this indication is $11,103. Visit www.cyramza.com.
✦ June 10: The FDA gave another indication to Bristol-Myers Squibb Co.’s Opdivo (nivolumab) for people with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. The recommended dose is a 240 mg intravenous infusion every two weeks or 480 mg every four weeks. Website Drugs.com lists the price of a 240 mg/24 mL vial as $6,879.49. Visit www.opdivo.com.