Roche's Tecentriq extends its hot streak with liver cancer combo breakthrough

tecentriq
If Roche can grab a first-line liver cancer approval for Tecentriq, it'll be the first I-O drugmaker to do so. (Roche)

Roche’s Tecentriq is on a much-needed hot streak.

On Tuesday, the immuno-oncology drug—in combination with Roche’s Avastin—picked up a breakthrough therapy designation from the FDA in previously untreated liver cancer patients, putting it on the path to a speedy approval.

The agency based the decision on phase 1b data, presented at last month’s American Society of Clinical Oncology annual meeting, that showed the Tecentriq-Avastin pairing could provoke a response in 65% of study patients at a median 10.3 months of follow-up.

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

First-line liver cancer would be a new market for Tecentriq, which currently boasts approvals only in the hotly contested bladder cancer and non-small cell lung cancer (NSCLC) markets. Right now, Bristol-Myers Squibb’s Opdivo is the only I-O drug to bear a liver cancer nod, though its indication is for patients who have previously been treated with Bayer’s Nexavar.

RELATED: Bristol-Myers' I-O star Opdivo steps up to challenge Bayer's Stivarga in liver cancer

And Tecentriq has been making headlines recently in some other new-to-immunotherapy markets, too. Earlier this month, it posted positive data in a tough-to-treat form of breast cancer, and in late June it nabbed a victory in a form of small-cell lung cancer.

Still, Tecentriq’s biggest recent win—at least in terms of sales potential—may have come in late May. The company unveiled a top-line win in previously untreated NSCLC for a combination of Tecentriq and chemo that could keep it in the conversation with market leader Keytruda from Merck.  

RELATED: Roche's Tecentriq grabs badly needed lung cancer win to keep Keytruda in its sights

Meanwhile, a liver cancer approval could also mean a new sales avenue for Avastin, an older drug that biosimilars makers are circling. Last September, Amgen and Allergan picked up an FDA approval for a cheaper version of the product, but it’s still unclear when the copy, dubbed Mvasi, will launch.

Suggested Articles

Proxy advisers will soon weigh in on BMS' $74 billion Celgene buyout, and their verdicts could sway undecided shareholders, analysts say.

No evidence of suspicious payments to Greek officials have been found, according to Novartis' own investigation and a report by a Greek expert panel.

Biogen investors' worst fears have come true: It's giving up on Alzheimer's prospect aducanumab. Is it “buy or be bought” time for the Big…