Roche has now joined Bristol-Myers Squibb and Merck in the inner circle of checkpoint inhibitor developers to make it to the commercial market. The FDA announced today that it has approved Roche’s atezolizumab for a common kind of bladder cancer called urothelial carcinoma.
The drug will be marketed by Genentech as Tecentriq and sold for $12,500 a month, in parity with rivals Opdivo and Keytruda.
The accelerated OK is based on Phase II data and comes four months ahead of the PDUFA date on the agency’s decision, highlighting once again the FDA’s intense interest in speeding along a new class of cancer drugs that has been making a deep impression on their therapeutic potential.
While Merck ($MRK) and Bristol-Myers ($BMY) made their mark with PD-1 drugs, Roche ($RHHBY) has been concentrating on PD-L1, a complementary pathway involved in the deceptive game cancer cells play to avoid an immune system attack. And Roche has been paying careful attention in identifying the patients most likely to benefit.
The approval follows positive results from a single-arm study involving 310 patients. “In all patients,” the FDA reported, “14.8 percent of participants experienced at least a partial shrinkage of their tumors, an effect that lasted from more than 2.1 to more than 13.8 months at the time of the response analysis. In patients who were classified as 'positive' for PD-L1 expression, 26 percent of participants experienced a tumor response (compared to 9.5 percent of participants who were classified as 'negative' for PD-L1 expression).”
The FDA also approved the Ventana PD-L1 (SP142) assay to detect PD-L1 protein expression levels on patients’ tumor-infiltrating immune cells.
Roche has only just begun to rack up likely approvals for this drug, which a number of analysts believe can score around $2.5 billion in annual sales by 2020. By the end of last year the pharma giant had set up 11 Phase III studies in a program involving 36 studies. And it has singled out atezo as one of the most important drugs in the pipeline.
Next up in the field of top contenders: AstraZeneca ($AZN), which has the fourth checkpoint inhibitor--also a PD-L1--lining up for an approval. AstraZeneca's durvalumab has fallen well behind the leaders, though, and will likely find it hard carving out market share as the fourth entry. For now, Roche has the PD-L1 arena to itself.
“Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in an FDA news release. “Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells.”
- here's the release