Roche Joins Immuno-Oncology Market with FDA Approval of AtezolizumabBy
Roche has joined the commercial race in the immuno-oncology market following the granting of accelerated approval by the US Food and Drug Administration for Tecentriq (atezolizumab) for treating bladder cancer. The drug was approved for the treatment of people 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). Urothelial carcinoma accounts for 90% of all bladder cancers.
The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to directly bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells.
Atezolizuma joins the now commercial leaders in the immuno-oncology market, two PD-1/PD-LI immune checkpoint inhibitors: Bristol-Myers Squibb's Opdivo (nivolumab) and Merck & Co.'s Keytruda (pembrolizumab), both slated as potential blockbusters.
Opdivo was approved this week by the FDA for its fourth cancer indication: for treating patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin. It is also approved to treat unresectable or metastatic melanoma, metastatic non-small cell lung cancer, and advanced renal cell carcinoma. It is also approved as combination regime with Bristol-Myers Squibb’s Yervoy for treating advanced melanoma.
Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma. It is also indicated for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.