The US Food and Drug Administration has expanded the approval of Roche’s Tecentriq so that it can be used to treat a wider range of patients with bladder cancer.
The regulator has now cleared the drug’s use to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
The drug was previously cleared for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery or after surgery.
Up to half of all people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment and therefore have a high unmet medical need, noted Roche group Genentech.
“It is encouraging to see continued progress in the treatment of advanced bladder cancer, which until last year had not seen any major advancements in more than 30 years,” said Andrea Maddox Smith, chief executive of the Bladder Cancer Advocacy Network.
“We are excited that Tecentriq is now a treatment option for people with advanced bladder cancer who are unable to receive a cisplatin-based chemotherapy as an initial treatment.”
Tecentriq (atezolizumab) has been granted an accelerated approval based on tumour response rate and duration of response seen in the Phase II IMvigor210 study, which means that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Meanwhile, in further good news for Roche, the US regulator also cleared Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy.
With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular oedema, a complication of diabetic retinopathy that causes swelling in the back of the eye.