AstraZeneca Iressa approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAstraZeneca's epidermal growth factor receptor agent Iressa (gefitinib) clears FDA May 5 "as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies." The accelerated approval is based on a 10% response rate seen in Phase II trials, which the agency said was in line with previous oncology approvals under Subpart H. The Iressa approval became controversial after the Phase III INTACT trials failed to show a benefit in survival, symptom improvement or quality of life when Iressa was added to traditional chemotherapy in treatment-naïve patients. AstraZeneca will conduct three trials to confirm Iressa's clinical benefit with survival, time to progression and symptom improvement endpoints. The drug will be available in mid-May at a wholesale price of $1,560 per mont
You may also be interested in...
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.
While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.