It’s better late than never for an FDA approval for the first subcutaneous PD-L1 inhibitor, which was doled out to Roche’s Tecentriq Hybreza after manufacturing delays derailed the company's initial launch plans last year.

The agency was originally slated to issue its verdict on Tecentriq in its under-the-skin formulation last September but the drug’s manufacturing processes needed updating, Roche’s delivery technology partner Halozyme Therapeutics said in a filing at the time. The tweaks, which a Roche spokesperson said were made in response to the FDA’s evolving requirements, were expected to wrap up in 2023 to support a 2024 launch. The world-first approval for the formulation came in the U.K. last year. 

Now, the therapy has been cleared for use in the U.S. in all of the Tecentriq adult formulation's indications, including types of lung, liver, skin and soft tissue cancers. The new version uses Halozyme’s Enhanze drug delivery tech to subcutaneously inject the product over seven minutes, compared to the 30 to 60 minutes needed for an IV infusion.

“By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” Roche’s chief medical officer and head of global product development Levi Garraway, M.D., Ph.D., said in a press release.

In a phase 2 study, 71% of patients preferred the subcutaneous version over the standard formulation, with many citing increased comfort during treatment, less time in the clinic and reduced emotional distress. Roche reported that 79% of patients who tried both formulations opted to continue their treatment with Tecentriq Hybreza.

Halozyme’s Enhanze technology is based on a proprietary recombinant human hyaluronidase enzyme, which allows the therapy to more quickly disperse and absorb into the bloodstream.

The delivery tech has played a part in improving ease of administration for other big-name cancer therapies such as Johnson & Johnson’s Darzalex Faspro and potentially Bristol Myers Squibb’s Opdivo, which has yet to receive approval as a subcutaneous option. 

While Tecentriq Hybreza has now beat Opdivo to the punch as the first subcutaneous checkpoint inhibitor cleared by the FDA, the agency’s verdict on the new Opdivo formulation is expected to come later this year.

Tecentriq was first approved in 2016 and took home CHF 3.77 billion ($4.44 billion) in 2023 sales. In areas crowded with formidable rivals such as Merck’s Keytruda in non-small cell lung cancer (NSCLC), Roche is “still holding our own” in the U.S., pharma chief Teresa Graham said on a February conference call.