Roche’s Genentech unit has been granted a speedy FDA approval for PD-L1 inhibitor Tecentriq as a first-line treatment for bladder cancer, extending its use beyond second-line therapy.
The US regulator has given the go-ahead to Tecentriq (atezolizumab) for use in locally advanced or metastatic urothelial carcinoma (mUC) patients who are not eligible for cisplatin chemotherapy, based on the results of the mid-stage IMvigor210 study. Last year the FDA granted conditional approval to Tecentriq or mUC patients whose disease has progressed during or after platinum-based chemotherapy.
The new OK is a stepwise increase in the number of bladder cancer patients eligible for treatment with Tecentriq and keeps the product’s nose ahead of rival checkpoint inhibitors from Bristol-Myers Squibb and Merck & Co, which both reached the market ahead of Roche’s drug for other cancer indications.
Tecentriq had a few months as the only immuno-oncology drug available for bladder cancer but BMS claimed a second-line approval in mUC for its Opdivo (nivolumab) drug from the FDA in February, while Merck’s Keytruda (pembrolizumab) has been filed for approval in first-line platinum-ineligible mUC patients as well as second-line after chemotherapy.
Roche is going all out to try to maintain its lead in the fifth most common form of cancer and is also conducting a phase III trial (IMvigor211) comparing the drug directly to first-line chemotherapy in mUC. Results from that trial are due in November and if positive Tecentriq could become an option for most first-line patients.
Bladder cancer affects almost 400,000 people a year and kills around 150,000 but has proved to be remarkably resistant to new drug therapy. Prior to the advent of immuno-oncology drugs, there had been no new treatments for patients with metastatic bladder cancer whose disease progressed despite platinum-based chemotherapy for 30 years.
Meanwhile Tecentriq has also started to muscle into territory held by Opdivo and Keytruda, getting an FDA approval last October in second-line non-small cell lung cancer (NSCLC). The reality is that in time the three drugs – along with newer entrants such as Merck KGaA and Pfizer’s Bavencio (avelumab) – will be competing across multiple indications for a share of a market predicted to reach at tens of billions of dollars in the coming years.