In Immuno-Oncology’s Latest Win, FDA OK’s Genentech Drug

Xconomy San Francisco — 

South San Francisco, CA-based Genentech, a division of international health giant Roche, announced today the U.S. approval of its drug atezolizumab (Tecentriq) for the most common form of bladder cancer.

Nearly 77,000 new cases of the cancer, called urothelial carcinoma, will occur in the U.S. this year, and it will cause more than 16,000 deaths, according to the National Cancer Institute. The FDA approved atezolizumab for patients with advanced disease or who have not been helped by platinum chemotherapy or surgery.

Beyond giving bladder cancer patients another treatment option, the approval is notable because atezolizumab is a so-called checkpoint inhibitor, a new class of immunotherapy drugs that disrupt a signaling system that tumors use to hide from immune attack. The first checkpoint inhibitor, ipilimumab (Yervoy), was approved in 2011 to treat advanced skin cancer. Two more, nivolumab (Opdivo) and pembrolizumab (Keytruda) followed in 2014, and have since been approved for other cancers of the lung and kidney, ushering a wave of hope that immunotherapy would start to provide cures for a wide range of cancer types.

That hope has been tempered by the realization that checkpoint inhibitors only work in a minority of patients whose immune systems already seem primed to receive a boost. The same goes for atezolizumab, which blocks a protein called PD-L1. Alongside the drug, the FDA approved a test from Roche’s diagnostic unit Ventana that measures a patient’s PD-L1 levels to help doctors sort out who might benefit most from atezolizumab.

The FDA approved atezolizumab based on a 310-patient study. All received the drug; there was no placebo group for comparison. The main goal was to show the drug was shrinking the patients’ tumors. According to the agency, 14.8 percent of the patients had at least a partial shrinkage, but there was a notable split based on PD-L1 levels. In patients classified as positive for PD-L1 expression, 26 percent had tumor shrinkage, according to the FDA, compared with only 9.5 percent of patients classified as negative.

Many other patients could require combinations of checkpoint inhibitors and other cancer treatments to see a similar benefit. Dozens of drug companies are racing to test combinations and develop new types of immunotherapy.

Genentech will price atezolizumab at $12,500 a month, per patient, according to this report from the Wall Street Journal. That puts it in line with the other approved immunotherapy drugs. Nivolumab and Pembrolizumab, for instance, both cost $150,000 per year, per patient.

Some of the most common serious side effects associated with atezolizumab include urinary tract infections, anemia, fatigue, dehydration, blood in the urine, difficulty breathing, and abdominal pain.