Imfinzi Approved for Bladder Cancer
May 1, 2017 – The U.S FDA has granted accelerated approval for Imfinzi™ (durvalumab), manufactured by AstraZeneca. Imfinzi is a programmed death ligand 1 (PD-L1) inhibitor approved for use in patients whose locally advanced or metastatic urothelial carcinoma (bladder, ureter and/or urethra cancer) progresses during or following platinum-containing chemotherapy. Urothelial carcinoma also is called transitional cell carcinoma because it usually begins in the transitional cells that line the urinary tract. It is the most common form of bladder cancer, affecting nearly 80,000 Americans each year.
Imfinzi is also indicated for patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Recommended dosing is 10mg/Kg of body weight once every two weeks as a one-hour intravenous (IV) infusion. Imfinzi will be available in single use vials that each contain either 500mg of Imfinzi in 10mL of solution or 120mg of the medication in 2.4mL of solution and is anticipated to cost more than $150,000 annually.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.