Tecentriq Still on Track for FDA Approval Despite Phase 3 Failure
Earlier this year Roche’s immune-oncology drug Tecentriq failed a bladder cancer trial, putting a conditional approval by the FDA in jeopardy. But the threat has since been dissolved.
After recent discussions with the agency, the company expects Tecentriq’s accelerated approval “will be maintained,”explained a spokeswoman with Genentech, the company’s US unit, reports Fierce Pharma.
This applies to Tecentrqiq’s green light in previously untreated patients ineligible for cisplatin chemo and in patients who’ve had previous platinum therapy, she explained. Both approvals cover patients with metastatic disease.
The news will be greeted with relief, especially since Tecentriq is up against some stiff competition, including PD-1/L1 market leaders Opdivo and Mercj, as well as two newer entrants from Pfizer and Merck KGaA’s Bavencio and AstraZeneca’s Imfinzi.
The med was first approved in the field based on phase 2 data showing durable response, but the trial unveiled in May to prove that it could in fact prolong patient’s lives.
“We assume that this will put this indication at risk of being removed from the label,” Leerink analyst Seamus Fernandez said, noting that the results were unexpected. “This comes as a surprise to us, considering Merck’s Keytruda showed an overall survival benefit.”
However, Roche will still have to ensure that they generate confirmatory data in the second-line setting. “The FDA indicated that additional evidence is needed for confirmation of clinical benefit to support regular approval” for the indication in previously treated patients,” the spokeswoman said, “and that substantial evidence may be obtained from other ongoing trials.”