Genentech's Tecentriq receives FDA-accelerated approval for advanced bladder cancer treatment
Roche Group member Genentech has received accelerated approval from the US Food and Drug Administration (FDA) for Tecentriq (atezolizumab) to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) who are unable to undergo cisplatin chemotherapy.
Tecentriq previously received approval to treat people with locally advanced or mUC showing disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
The safety and effectiveness of Tecentriq on children is still not known.
Bladder cancer is a common form of urothelial carcinoma.
Nearly 50% of all people with the advanced form of the disease cannot receive cisplatin chemotherapy as an initial treatment requiring high unmet medical need.
Tecentriq is a monoclonal antibody designed to bind with the protein PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, thereby blocking its interactions with both PD-1 and B7.1 receptors.
By isolating PD-L1, Tecentriq can enable T-cell activation, while the drug may also affect normal cells.
The medication can be used in bladder cancer when it cannot be removed by surgery or the patient is unable to take chemotherapy containing a medicine called cisplatin.
Genentech global product development chief medical officer and head Sandra Horning said: “We are pleased that Tecentriq will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy.
“Tecentriq was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose disease has progressed after receiving other medicines, either before or after surgery, or after their disease has spread.”
The Accelerated Approval Programme of FDA provides conditional approval of a medicine based on initial evidence of clinical benefit, particularly when it fills an unmet medical need for a serious condition.
Tecentriq has been approved under accelerated approval based on the Phase II IMvigor210 study under tumour response rate and duration of response.
The company noted that this is the third approval for Tecentriq in under a year, which has also been approved to treat patients with metastatic non-small-cell lung cancer (NSCLC).
In addition to Tecentriq (atezolizumab), Genentech has also received FDA approval for 0.3mg of Lucentis (ranibizumab injection) for the monthly treatment of all forms of diabetic retinopathy.