Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.

The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday.

“These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said.

Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024.

Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last week, British authorities became the first to approve the subcutaneous drug.

The FDA revisions won’t affect the supply of Tecentriq SC outside of the U.S., the Genentech spokesperson said.


RELATED: Chasing Roche, Merck talks up subcutaneous Keytruda ahead of phase 3 data drop

Subcutaneous Tecentriq cuts the drug’s administration time to seven minutes, from about 30 minutes to 60 minutes for an infusion. It “offers far more convenience to patients and [healthcare professionals]” and frees up resources in “highly constrained” healthcare systems, Roche’s pharma chief Teresa Graham said during a call in July.

Despite the delay, Tecentriq will likely still be the first PD-1/L1 inhibitor to have a subcutaneous version approved by the FDA.

Merck could be next with Keytruda. The phase 3 MK-3475-A86 trial, which is testing subcutaneous Keytruda against the IV form in non-small cell lung cancer, reached its primary completion date in April. Merck has yet to report the results.

Merck expects that its subcutaneous formulations—including a separate once-every-six-week version—could eventually address half of all Keytruda patients, CEO Rob Davis said during a call in April.

For Roche, its subcutaneous Tecentriq is made possible by Halozyme’s Enhanze drug delivery technology, which involves a recombinant human hyaluronidase enzyme to improve the drug’s uptake by the body.

For its part, Merck’s close-to-market subcutaneous version of Keytruda doesn’t contain hyaluronidase. The company’s longer-term focus centers on a version that does contain the enzyme, which would allow the drug to be dosed every six weeks rather than three. That candidate is still years away, with a phase 1 expected to read out in 2026.

The Enhanze technology is also used in Roche’s proposed subcutaneous formulation of its blockbuster multiple sclerosis antibody Ocrevus. The drug just matched up to IV Ocrevus in patients with relapsing forms of MS or primary progressive MS in the phase 3 OCARINA II trial. Roche plans to file the results with regulators globally this year, Graham said during the July call.

Back in June, the FDA cleared Argenx’s subcutaneous Vyvgart for the treatment of generalized myasthenia gravis. That product, which also utilizes Halozyme’s Enhanze, also experienced a three-month delay with its FDA review.