FDA Approves Atezolizumab

May 19, 2016
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Genentech received accelerated approval for its immunotherapy atezolizumab for the treatment of bladder cancer.

On May 18, 2016 FDA approved Genentech’s atezolizumab injection, a monoclonal antibody for the treatment of urothelial carcinoma, or bladder cancer. Atezolizumab an anti-PDL1 cancer immunotherapy, Genentech said in a press announcement. Genentech is a subsidiary of Roche.

The drug was granted accelerated approval by FDA, based on a clinical trial of 310 patients with locally advanced or urothelial carcinoma. Results of the trial indicated that atezolizumab reduced tumor size in 14.8% of patients, 5.5% of those patients showed complete response to the drug. Genentech says it expects the drug will be available for patients in the US in one to two weeks. In a summary of the approval, FDA notes the drug appeared to be most effective for patients that had high levels of PD-L1 expression in tumors during treatment. While testing for PD-L1 is not required for treatment with atezolizumab, FDA continued, it might help “guide patient selection.”

According to the American Cancer Society, there will be an estimated 76,960 new cases of bladder cancer in the US during 2016 alone. Bladder cancer is the fourth most common cancer in men, but is less common in women. Urothelial carcinoma accounts for approximately 90% of all cases of bladder cancer in the US, according to the National Cancer Institute.

Immuno-oncology is new territory for pharmaceutical companies, many of which have been rushing to enter the market over the past several months. Companies like Merck and Bristol-Myers Squibb have seen significant return on their investments in immunotherapies. Merck received accelerated approval for Keytruda (pembrolizumab), its treatment for lung cancer in tumors that express PD-L1, in early October 2015. Bristol-Myers Squibb’s Yervoy (ipilimumab)/Opdivo (nivolumab) combination drug to treat metastatic melanoma received accelerated approval from FDA in September 2015. Both Keytruda and Yervoy/Opdivo are expected to be competitors with atezolizumab, since all three drugs work as PD-L1/PD-1 inhibitors. Other biopharma companies are also announcing plans to invest in R&D in immuno-oncology; Celgene announced on May 17, 2016 that it will pay Agios Pharmaceuticals $200 million in a collaboration focused on metabolic immuno-oncology.

Source: FDA, Genentech