FDA grants Genentech’s cancer immunotherapy Tecentriq Accelerated Approval for people with a specific type of advanced bladder cancer

First and only anti-PDL1 cancer immunotherapy approved by the FDA.

“Tecentriq is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy,” said Sandra Horning, chief medical officer and head of Global Product Development. “We thank the scientists, doctors, patients and their families who made it possible to bring Tecentriq to people with advanced urothelial carcinoma.”

"Even though bladder cancer is the fifth most commonly diagnosed cancer in the US, 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. “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 indication for Tecentriq is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Today’s approval of Tecentriq is based on the Phase II IMvigor 210 study.

Possible serious side effects with Tecentriq include, but are not limited to, lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis), hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas), nervous system problems (neuropathy and meningoencephalitis), eye problems, severe infections and severe infusion reactions. Additional information on these and other side effects can be found below.

Tecentriq will be available to people in the US within one to two weeks.