Genentech's Bladder Cancer Drug Gains Priority Review by the FDA

Published: Mar 16, 2016

Genentech's Bladder Cancer Drug Gains Priority Review by the FDA
March 15, 2016
By Mark Terry, Breaking News Staff

South San Francisco-based Genentech , a member of the Roche Group (RHHBY) announced today that its cancer drug, atezolizumab, had been granted Priority Review status by the U.S. Food and Drug Administration (FDA).

The FDA simultaneously accepted Genentech’s Biologics License Application (BLA). Atezolizumab is being evaluated to treat patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease has progressed during or after platinum-based chemotherapy in the metastatic setting. Also, it is being studied for patients whose disease grew worse within 12 months of platinum-based chemotherapy before surgery or after surgery. Urothelial carcinoma is responsible for 90 percent of all bladder cancers.

“Atezolizumab was granted Priority Review designation based on results of the IMvigor 210 study, which showed the medicine shrank tumors in a type of advanced bladder cancer, and the majority responding to treatment continued to respond after nearly a year of follow up,” said Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, in a statement. “The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible.”

The FDA will make a decision on approval by Sept. 12.

In other Genentech news, Burnaby, British Columbia-based Xenon Pharmaceuticals provided updates today on two ongoing collaborations with Genentech. First, Xenon’s collaboration focused in identifying and developing selective inhibitors of Nav1.7 to treat pain has been extended. Second, a collaboration focused on pain genetics, has also been extended for another year until March 2017.

The first collaboration was announced in 2012. Xenon used its Extreme Genetics discovery platform, which identified Nav1.7 as a potential drug target for pain. This research has moved into the clinic with Phase I clinical trials for GDC-0276 and GDC-0310. Genentech hopes to move them into Phase II this year after full analysis of the data.

The second collaboration uses Xenon’s Extreme Genetics discovery platform to identify targets in patients with rare disorders that give them an inability to perceive pain, or individuals who have non-precipitated spontaneous severe pain.

In terms of its bladder cancer treatment, MPDL3280A, it is a monoclonal antibody that binds to a protein known as programmed death ligand-1 (PD-L1). Atezolizumab binds directly to PD-L1 on tumor cells and keeps it from interacting with PD-1 and B7.1 receptors. PD-L1 effectively allows tumor cells to hide from the body’s immune system. Atezolizumab, then, appears to shut off the cancer cells’ ability to hide from the body’s T cells.

Often anti-PD-L1 drugs are combined with drugs that stimulate the immune system. This is roughly equivalent to taking one foot off the brake and one foot on the gas simultaneously.

On Jan. 8, Roche released data from the IMvigor 210 Phase II study. It also was conducting IMvigor 211, a Phase III study that compared atezolizumab with standard-of-care chemotherapy in patients with mUC.

For the 210 study, atezolizumab shrank tumors in 15 percent of people who were able to be evaluated and whose disease progressed after platinum-based chemotherapy. It shrank tumors in 26 percent of patients who showed medium or high levels of PD-L1 expression.

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