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.
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.
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.
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.