Please login to the form below

Not currently logged in
Email:
Password:

Roche claims another FDA green light for Tecentriq

Wins approval for the treatment's first-line use in bladder cancer

Roche

Roche's Genentech unit has been granted a speedy FDA approval for PD-L1 inhibitor Tecentriq as a first-line treatment for bladder cancer, extending its use beyond second-line therapy.

The US regulator has given the go-ahead to Tecentriq (atezolizumab) for use in locally advanced or metastatic urothelial carcinoma (mUC) patients who are not eligible for cisplatin chemotherapy, based on the results of the mid-stage IMvigor210 study. Last year the FDA granted conditional approval to Tecentriq or mUC patients whose disease has progressed during or after platinum-based chemotherapy.

The new OK is a stepwise increase in the number of bladder cancer patients eligible for treatment with Tecentriq and keeps the product's nose ahead of rival checkpoint inhibitors from Bristol-Myers Squibb and Merck & Co, which both reached the market ahead of Roche's drug for other cancer indications.

Tecentriq had a few months as the only immuno-oncology drug available for bladder cancer but BMS claimed a second-line approval in mUC for its Opdivo (nivolumab) drug from the FDA in February, while Merck's Keytruda (pembrolizumab) has been filed for approval in first-line platinum-ineligible mUC patients as well as second-line after chemotherapy.

Roche is going all out to try to maintain its lead in the fifth most common form of cancer and is also conducting a phase III trial (IMvigor211) comparing the drug directly to first-line chemotherapy in mUC. Results from that trial are due in November and if positive Tecentriq could become an option for most first-line patients.

Bladder cancer affects almost 400,000 people a year and kills around 150,000 but has proved to be remarkably resistant to new drug therapy. Prior to the advent of immuno-oncology drugs, there had been no new treatments for patients with metastatic bladder cancer whose disease progressed despite platinum-based chemotherapy for 30 years.

Meanwhile Tecentriq has also started to muscle into territory held by Opdivo and Keytruda, getting an FDA approval last October in second-line non-small cell lung cancer (NSCLC). The reality is that in time the three drugs - along with newer entrants such as Merck KGaA and Pfizer's Bavencio (avelumab) - will be competing across multiple indications for a share of a market predicted to reach at tens of billions of dollars in the coming years.

Article by
Phil Taylor

19th April 2017

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Pegasus

Pegasus inspires healthy decisions through creative, inspirational and integrated communications. Working with ambitious clients, we deliver big ideas and far-reaching...

Latest intelligence

Beyond the event
...
Anthill Agency and Actando partnership to Transform Pharma's Digital Skills
Anthill Agency, a leading life sciences digital agency, today announced the launch of the Anthill Academy™ and partnership with Actando's PharmAcademy....
Is the pharma business model ready for precision medicine?
Precision medicine promises to revolutionise patient outcomes and reduce costs for industry but is pharma ready for it? Blue Latitude Health co-founder Head of Strategy Fred Bassett explores the challenges...

Infographics