Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Genentech’s Immunotherapy Gets Accelerated FDA Approval for Advanced Bladder Cancer



The immunotherapy agent as previously approved to treat patients with locally advanced or mUC who have shown disease progression following chemotherapy or surgery.

Share this!

April 19, 2017 | by Sarah Hand, M.Sc.

Genentech’s PD-L1 inhibitor, Tecentriq, has just gained another indication from the FDA. The immunotherapy has been granted accelerated approval by the regulator for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC).

Bladder cancer patients who are unable to be treated using cisplatin chemotherapy may be eligible for treatment with Tecentriq. The immunotherapy agent as previously approved to treat patients with locally advanced or mUC who have shown disease progression following chemotherapy or surgery.

It’s estimated that up to 50 percent of all people with advanced urothelial carcinoma – the most common of which is bladder cancer – are unable to be treated using cisplatin chemotherapy. These patients face few treatment options, and as a result, are in need of alternative therapies.

“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 Dr. Sandra Horning, 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.”

The accelerated approval of Tecentriq was based on the results on a Phase II clinical trial, dubbed IMvigor210. Of the 119 patients enrolled in Cohort 1 of the trial, 23.5 percent responded to treatment with the immunotherapy. Tecentriq is currently being evaluated in a Phase III clinical trial to confirm these results, which could support continued approval for this indication by the FDA.

“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.”

Tecentriq is a monoclonal antibody which binds to the PD-L1 protein displayed on tumor cells. This inhibitory effect may activate the T cells of the immune system. In October of 2016, Tecentriq was first approved to treat patients with metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression after receiving chemotherapy.

Keywords:  Immunotherapy, FDA, Bladder Cancer


Share this with your colleagues!

Early Alzheimer’s Patients May See Benefit from Anti-Epilepsy Drug

June 27, 2017 - While the processes behind Alzheimer’s disease development aren’t fully understood, recent research has suggested that some cognitive decline could be caused by seizure-like activity in the brains of patients.

Featured In: Clinical Trials News

First Human Colon Organoids Grown in Lab

June 26, 2017 - Using human pluripotent stem cells, researchers at Cincinnati Children's Hospital Medical Center have developed colon-like organoids that can be transplanted into mice.

Featured In: Life Science News

Could Genetic Markers Help Identify Patients at Risk of Opioid Overdose?

June 26, 2017 - Researchers at Erasmus University Medical Center in the Netherlands have identified 10 genes which may help healthcare providers predict which patients could respond poorly to opioid medications.

Featured In: Drug Safety News


Top 5 Most Impactful Tweets in Drug Development During the Last Week


Serialized? Yes. But are Products Still Being Diverted?

Quantitative Protein Profiling in FFPE to Characterize Toxicities Associated with Immune Checkpoint Inhibitors

Are You Choosing the Right Model? A Guide to Selecting Your Next Immuno-Oncology Model

Imaging-based Subtypes of Pancreatic Cancer

Copyright © 2016-2017 Honeycomb Worldwide Inc.