FDA Approves Tecentriq
May 19, 2016 – The U.S. Food and Drug Administration (FDA) approved Tecentriq™ (atezolizumab) manufactured by Genentech for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The recommended dose of Tecentriq is 1200mg as an intravenous infusion over 60 minutes once every 3 weeks and is expected to cost approximately $150,000 per year. Each year in the U.S., approximately 76,000 patients are diagnosed with bladder cancer and Urothelial carcinoma is the most common type of bladder cancer; it can also be found in the renal pelvis, ureter and urethra. Tecentriq is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. It is an immunotherapy that helps the body’s immune system attack cancer cells. Tecentriq is a breakthrough therapy that was granted accelerated approval. Tecentriq is expected to be launched within 1 to 2 weeks and will be available through a limited network of specialty pharmacies.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.