Bladder Cancer Indication Extended for Tecentriq
April 18, 2016 – The U.S. FDA granted Genentech an expanded indication for Tecentriq® (atezolizumab). Tecentriq is now approved for the first-line treatment of locally advanced or metastatic urothelial carcinoma (cancer of the bladder, renal pelvis, ureters and/or urethra) in patients who are not able to receive chemotherapy with cisplatin. Tecentriq is an immunotherapy; a programmed death receptor-ligand 1 (PD-L1)-blocking antibody that helps the body’s immune system attack cancer cells. Originally, Tecentriq was approved on May 18, 2016 for the second-line treatment of certain patients with advanced urothelial carcinoma. It has an additional indication to treat certain patients with metastatic non-small cell lung cancer (NSCLC), as well. Recommended dosing is one 60-minute infusion containing 1200mg Tecentriq once every three weeks until the cancer gets worse or the patient cannot take treatment any longer.
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 1-800-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.