SWITZERLAND — Roche’s eagerly awaited subcutaneous version of its groundbreaking cancer immunotherapy Tecentriq may not receive its anticipated FDA decision on time.

The FDA was set to deliver a verdict on subcutaneous Tecentriq within the next week, but a manufacturing process update is now in the works, as confirmed by Roche’s drug delivery technology partner, Halozyme Therapeutics, in a recent securities filing.

Halozyme disclosed, “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.”

The reason behind these unexpected adjustments lies in the FDA’s evolving requirements, explained a spokesperson from Roche’s Genentech unit. As a result, Roche is now looking forward to an FDA approval in 2024.

Roche initially submitted the subcutaneous formulation to both the FDA and the European Medicines Agency in November.

This version of Tecentriq aims to cover all the existing indications of the original intravenous version, with British authorities already granting approval for its use.

Despite this delay, the subcutaneous Tecentriq remains poised to be the first PD-1/L1 inhibitor to receive FDA approval in this format.

The next in line is Merck’s Keytruda, which is currently undergoing a phase 3 trial comparing its subcutaneous form to the intravenous version in non-small cell lung cancer patients. However, Merck is yet to reveal the trial’s results.

Merck’s CEO, Rob Davis, has expressed optimism, stating that their subcutaneous formulations, including a less frequent dosing option, could eventually cater to half of all Keytruda patients.

The key to Roche’s subcutaneous Tecentriq lies in Halozyme’s Enhanze drug delivery technology, which incorporates a recombinant human hyaluronidase enzyme to enhance the drug’s absorption by the body.

In contrast, Merck’s subcutaneous Keytruda doesn’t contain hyaluronidase. Merck’s future plans revolve around developing a version that does, potentially allowing for dosing every six weeks.

However, this candidate remains several years away, with a phase 1 trial expected to yield results in 2026.

Notably, Roche also employs the Enhanze technology in its proposed subcutaneous formulation of the blockbuster multiple sclerosis antibody Ocrevus.

In the phase 3 OCARINA II trial, this subcutaneous version matched up to the intravenous Ocrevus in patients with relapsing forms of MS or primary progressive MS. Roche intends to present these results to regulators worldwide this year.

Earlier this year, the FDA cleared Argenx’s subcutaneous Vyvgart for the treatment of generalized myasthenia gravis.

This product, too, relies on Halozyme’s Enhanze technology, but it faced a three-month delay during its FDA review process, much like Roche’s Tecentriq.

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