FDA approves CYRAMZA (ramucirumab) for EGFR-mutated non-smal
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Food and Drug Administration approved ramucirumab (CYRAMZA, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.

• Efficacy was evaluated in a multinational, randomized, double-blind, placebo-controlled, multicenter study in patients with previously untreated metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

• A total of 449 patients were randomized (1:1) to receive either ramucirumab 10 mg/kg or placebo every 2 weeks as an intravenous infusion, in combination with erlotinib 150 mg orally once daily, until disease progression or unacceptable toxicity.

• Most common adverse reactions: infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema.

• The recommended dose of ramucirumab for metastatic NSCLC in combination with erlotinib is 10 mg/kg every 2 weeks.

Source: https://pxmd.co/fda
Like
Comment
Share