Release date- 17042017 - South San Francisco, CA- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TECENTRIQ (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
TECENTRIQ was previously approved for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). It is not known if TECENTRIQ is safe and effective in children. Bladder cancer is the most common type of urothelial carcinoma, and up to half of all people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment and therefore have a high unmet medical need. Urothelial carcinoma also includes cancers of the urethra, ureters and renal pelvis.
'We are pleased that TECENTRIQ will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy,' said Sandra Horning, M.D., chief medical officer and head of Global Product Development. 'TECENTRIQ was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose disease has progressed after receiving other medicines, either before or after surgery, or after their disease has spread.'
'It is encouraging to see continued progress in the treatment of advanced bladder cancer, which until last year had not seen any major advancements in more than 30 years,' said Andrea Maddox Smith, chief executive officer, Bladder Cancer Advocacy Network. 'We are excited that TECENTRIQ is now a treatment option for people with advanced bladder cancer who are unable to receive a cisplatin-based chemotherapy as an initial treatment.'
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. Today's approval of TECENTRIQ is based on the Phase II IMvigor210 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, meningitis and encephalitis), eye problems (inflammation of the eyes), severe infections and severe infusion reactions. Additional information on these and other side effects can be found below.
For those who qualify, Genentech offers patient assistance programs for people taking TECENTRIQ through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at http://www.Genentech-Access.com .
This is the third approval for TECENTRIQ in under a year. TECENTRIQ is also approved for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
About the IMvigor210 study
IMvigor210 is an open-label, multicenter, single-arm 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 the study were enrolled into one of two cohorts. This accelerated approval is based on results from Cohort 1, which consisted of 119 people with locally advanced or mUC who were ineligible for cisplatin-containing chemotherapy and were either previously untreated or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy. People in this cohort received a 1200-mg intravenous dose of TECENTRIQ every three weeks until either unacceptable toxicity or disease progression. The primary endpoint of the study was objective response rate (ORR).
A summary of the efficacy data from the IMvigor210 study that supports this accelerated approval is included below.
PD-L1 Expression Subgroups
< 5% in ICs1
= 5% in ICs1
Number of IRF-assessed Confirmed Responders
Complete Response (CR) (%)
Partial Response (PR)
Median DoR, months
IRF = Independent Review Facility
NR = Not reached
Denotes a censored value
1 PD-L1 expression in tumor-infiltrating immune cells (ICs)