Ogivri Launched as Herceptin Biosimilar
December 2, 2019
First Generics Approved for MS Drug Gilenya
December 6, 2019
Ogivri Launched as Herceptin Biosimilar
December 2, 2019
First Generics Approved for MS Drug Gilenya
December 6, 2019

New Lung Cancer Indication for Tecentriq

December 3, 2019 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Genentech. The product is now indicated for use in combination with chemotherapy (paclitaxel protein-bound and carboplatin) to provide first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults who have no EGFR or ALK genomic tumor aberrations.

The majority of lung cancer diagnoses in the United States are NSCLC, and this type of cancer can be divided into several different forms. Non-squamous forms, of which there are several, are forms that do not begin in the thin, flat cells that line the inside of the lungs. Once the cancer spreads to other parts of the body, it has become metastatic, and survival rates drop significantly compared to localized disease.

In a clinical study, Tecentriq in combination with chemotherapy improved median overall survival (18.6 months) compared to chemotherapy alone (13.9 months). It also improved median progression-free survival (PFS), achieving a median PFS of 7.2 months compared to 6.5 months with chemotherapy alone.

Recommended dosing for Tecentriq under the new indication is 1200mg administered via intravenous (IV) infusion every three weeks until disease progression or unacceptable toxicity. The first infusion should be administered over the course of 60 minutes. If the first infusion is tolerated, subsequent infusions can take place over the course of 30 minutes. Tecentriq should be administered prior to chemotherapy if given on the same day. Once four to six cycles of chemotherapy have been completed, recommended dosing for Tecentriq is 840mg every two weeks, 1200mg every three weeks, or 1680mg every four weeks.

Tecentriq carries two additional indications for NSCLC, as well as indications for urothelial carcinoma, triple-negative breast cancer, and small cell lung cancer. It first received FDA approval in 2016.