- Roche said Tuesday it had secured an accelerated approval from the Food and Drug Administration for Tecentriq (atezolizumab) in first-line use for patients with advanced or metastatic bladder cancer, expanding the label of the Swiss pharma's cancer immunotherapy.
- Tecentriq was already approved for treatment of bladder cancer following platinum-containing chemotherapy. The new accelerated approval for first-line use only covers those patients ineligible for cisplatin chemotherapy.
- With the expanded label, Roche stays one step ahead of the immunotherapy competition in bladder cancer. Others, including Merck and AstraZeneca, are seeking approval of their respective drugs in the same market.
Tecentriq is the first immunotherapy approved as an initial treatment in bladder cancer, despite being the third PD-1/PD-L1 inhibitor on the market. Roche targeted bladder cancer first as a way to secure market share in that indication ahead of Bristol-Myers Squibb and Merck, who had already won approval of their respective checkpoint inhibitors in melanoma and non-small cell lung cancer.
While Roche will need to supply further data for full approval for Tecentriq, it retains an edge over Bristol-Myers' Opdivo (nivolumab), which has accelerated approval for second-line treatment of patients following platinum-containing chemotherapy.
More competition is inbound. The FDA has accepted applications for approval of Merck & Co.'s Keytruda (pembrolizumab), Pfizer and Merck KGaA's Bavencio (avelumab) and AstraZeneca's durvalumab in second-line bladder cancer.
U.S. Merck successfully submitted a supplementary biologics license application for priority review in first-line use as well.
The FDA has set target review dates for all three drugs in the second and third quarters of this year, suggesting the bladder cancer market could become more competitive quickly.
Bladder cancer, or urothelial carcinoma, is the ninth most common cancer worldwide, causing around 145,000 deaths each year. Patients with metastatic urothelial carcinoma have a poor prognosis and few treatment options.
Roche has had a good week, also securing an expanded label for its injected eye drug Lucentis (ranibizumab) for diabetic retinopathy, with or without diabetic macular edema. This makes Lucentis — already approved for a range of eye diseases — the first and only drug approved to treat all forms of diabetic retinopathy.