Genentech Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years

Published: May 20, 2016

Genentech Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years May 19, 2016
By Mark Terry, Breaking News Staff

Genentech , headquartered in South San Francisco, announced yesterday that the U.S. Food and Drug Administration (FDA) gave its Tecentriq (atezolizumab) accelerated approval to treat specific types of advanced bladder cancer.

Tecentriq is a checkpoint inhibitor. Cancer cells often have mechanisms that allow them to hide from the immune system. A checkpoint inhibitor takes away that ability, leaving the cancer cells more exposed to the immune system. Tecentriq inhibits PD-L1. Checkpoint inhibitors are often combined with drugs that help stimulate and target the immune system.

In the area of immuno-oncology, Bristol-Myers Squibb ’s Opdivo has hit the market. It also inhibits PD-1. Others include Bristol-Myers Squibb’s Yervoy for melanoma, and Merck & Co. ’s Keytruda.

Although immuno-oncology is seen as a huge area of advancement in cancer treatment, reality appears to have set in now that it is starting to appear that checkpoint inhibitors don’t work in many patients. As Alex Lash writes in Xconomy, “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.”

Tecentriq has been approved to treat patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-based chemotherapy, or whose cancer got worse within 12 months of receiving platinum-based chemotherapy before surgery, or after surgery. Urothelial carcinoma is responsible for about 90 percent of all bladder cancers, and is also seen in the renal pelvis, ureter and urethra.

“Even though bladder cancer is the fifth most commonly diagnosed cancer in the United States, it hasn’t received the same attention within the cancer community as other common cancers,” said Diane Zipursky Quale, president and co-founder, Bladder Cancer Advocacy Network, in a statement. “Tecentriq is a new medicine for people whose locally advanced or metastatic bladder cancer has progressed on platinum-based chemotherapy and may have limited treatment options.”

The FDA’s Accelerated Approval Program gives conditional approval to drugs that fill an unmet medical need for a serious condition, and is based on early evidence. In this case, Tecentriq was approved on the basis of the Phase II IMvigor 2010 study. The primary endpoint of the study was objective response rate (ORR). In a subset of patients in the study, the drug shrank tumors in 22 percent of people.

The drug will be available in one or two weeks. It will be priced at $12,500 per month, which is about par with other immuno-oncology treatments. Examples include nivolumab (Opdivo) and pembrolizumab (Keytruda), which both run about $150,000 per year, per patient.

Tecentriq is also saddled with a plethora of serious potential side effects, including pneumonitis, hepatitis, colitis, hormone gland issues, neuropathy and meningoencephalitis, eye inflammation, infections, and infusion reactions. Less severe but more common side effects are feeling tired, decreased appetite, nausea, urinary tract infection, fever and constipation.

The FDA is also performing an accelerated review of the drug in patients with locally advanced or metastatic non-small cell lung cancer. And Genentech is proceeding with a late-stage study to evaluate Tecentriq in patients whose bladder cancer has progressed after at least one earlier platinum-containing treatment. Genentech also hopes to partner with other companies in evaluating combination therapies.

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