The FDA granted Accelerated Approval to Genentech’s Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.

“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, M.D., 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 U.S., 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 FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. The indication for Tecentriq is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The 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.

Tecentriq will be available to people in the U.S. within one to two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Tecentriq through Genentech Access Solutions.

Genentech is also evaluating Tecentriq in a confirmatory phase III study (IMvigor 211), which compares Tecentriq to chemotherapy in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.

IMvigor 210 was an open-label, multicenter, two-cohort phase II study that evaluated the safety and efficacy of Tecentriq in people with locally advanced or mUC, regardless of PD-L1 expression. People in a cohort of the study whose disease had progressed during or following previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen (n=310) received a 1200mg intravenous dose of Tecentriq on day one of 21-day cycles until unacceptable toxicity or either radiographic or clinical progression. The primary endpoint of the study was objective response rate (ORR) as assessed by an independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included duration of response (DOR). A summary of the efficacy and safety data from the IMvigor 210 study that supports this accelerated approval is included below. The median follow-up time for this cohort was 14.4 months.

In a subset of people in the IMvigor 210 study with disease progression following neoadjuvant or adjuvant platinum-containing therapy (n=59), Tecentriq shrank tumors (ORR) in 22% (95% CI: 12.3, 34.7) of people.

The most common Grade 3-4 adverse reactions (≥ 2%) were: urinary tract infection (9%), anemia (8%), fatigue (6%), dehydration, intestinal obstruction (partial or complete blockage of the bowel), urinary obstruction, hematuria (blood in the urine; 3%), dyspnea (difficulty breathing; 4%), acute kidney injury, abdominal pain (pain in stomach area; 4%), venous thromboembolism (blood clots in the vein), sepsis (blood infection) and pneumonia (lung infection). Three people (0.9%) experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death. Tecentriq was discontinued for adverse reactions in 3.2% (10) of the 310 patients.