Posted from: Monday, April 08, 2019 - 03:46 PM - Present

Tecentriq Receives New Lung Cancer Indication

March 18, 2019 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Roche, to be used in combination with chemotherapy (carboplatin and etoposide) as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in adult patients.

ES-SCLC is small cell lung cancer that has metastasized, and may affect tissues including both lungs, the lymph nodes, fluids outside of the lungs, bone marrow, and other areas of the body. Approximately two-thirds of patients are already in the extensive stage when first diagnosed with SCLC. This stage of small cell lung cancer can be difficult to treat, and advances in available therapies have been limited. The five-year survival rate for ES-SCLC is 19%, with the majority of patients surviving for less than one year after diagnosis.

In clinical studies, Tecentriq and chemotherapy produced median overall survival (OS) of 12.3 months and progression free survival (PFS) of 5.2 months compared to OS 10.3 months and PFS 4.3 months with chemotherapy alone. Recommended dosing for small cell lung cancer indications is 1200mg administered via intravenous (IV) infusion over the course of 60 minutes once every three weeks. Tecentriq should be administered on the same day as the patient’s chemotherapy. After the initial administration, infusion time can be reduced to 30 minutes if tolerated.

Tecentriq originally received FDA approval in 2016. The new indication is Tecentriq’s first for small cell lung cancer. The drug is also indicated to treat non-small cell lung cancer, triple-negative breast cancer, and urothelial carcinoma.

Last Updated Friday, June 14, 2019 - 04:59 PM.