Roche’s Genentech was supposed to get a priority review for its combo using Tecentriq and Avastin plus chemo in frontline lung cancer cases, with a deadline on the FDA’s decision set for Wednesday. And usually, that means a green light is on its way sooner rather than later.
But that didn’t happen.
Instead, the FDA says it will delay its decision three months so they can take into account some new information that the agency wanted to see first.
The extension allows the FDA time to review additional information requested in support of the sBLA. FDA determined that the submission of this information constituted a major amendment to the sBLA resulting in this extension of the PDUFA goal date. The FDA is expected to make a decision on approval by December 05.
The statement makes no reference to what regulators were asking for.
That’s a rare delay in this field, where regulators have been routinely stamping approvals on the first set of checkpoint drugs to make it to the market without raising the bar too high. And it will likely raise a few eyebrows among the rivals in the field carving up a blockbuster market.
Roche, which is playing the distant third-place position in the checkpoint field behind Merck and Bristol-Myers Squibb, had posted what appeared like a sure thing in this field. And they need it, with their revenue still only a fraction of what the leaders command.
Roche researchers detailed a doubling in 12-month progression-free survival rates among a broad group of non-squamous non-small cell lung cancer patients in the closely-watched IMpower150 study, compared to Avastin and chemo. Researchers have also reported that the triple Tecentriq regimen scored significant OS results, hitting 19.2 months compared to 14.7 months for the control arm.
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