Roche’s subcutaneous Tecentriq faces FDA setback due to manufacturing updates

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Roche may experience a delay in the FDA decision for its subcutaneous version of the cancer immunotherapy Tecentriq, as it needs to update the therapy’s manufacturing processes. The anticipated FDA verdict was originally set for next week. However, Roche’s drug delivery technology partner, Halozyme Therapeutics, revealed that these updates will likely continue into 2023, potentially resulting in a Tecentriq SC (subcutaneous) launch in the US in 2024.

The need for manufacturing adjustments arises from the FDA’s evolving requirements, according to a spokesperson from Roche’s Genentech unit. The company now anticipates FDA approval in 2024.

Roche submitted the subcutaneous Tecentriq formulation to both the FDA and the European Medicines Agency in November, aiming to target all existing indications of the original intravenous Tecentriq. Last week, British authorities granted the first approval for the subcutaneous drug.

Fortunately, the FDA revisions are not expected to impact the supply of Tecentriq SC outside of the US.

Subcutaneous Tecentriq offers a significant advantage by reducing administration time from 30 to 60 minutes for an infusion to just seven minutes. This not only provides convenience to patients and healthcare professionals but also alleviates pressure on healthcare systems facing constraints, as noted by Roche’s Pharma Chief Teresa Graham in July.

Despite the delay, Tecentriq is likely to become the first PD-1/L1 inhibitor with an FDA-approved subcutaneous version. Merck’s Keytruda may follow suit, with a phase 3 trial comparing the subcutaneous version to the intravenous form in non-small cell lung cancer. However, Merck has yet to report the results.

Merck envisions its subcutaneous Keytruda formulations, including a once-every-six-week version, catering to approximately half of all Keytruda patients, as stated by CEO Rob Davis in April.

Halozyme’s Enhanze drug delivery technology plays a crucial role in enabling Roche’s subcutaneous Tecentriq, employing a recombinant human hyaluronidase enzyme to enhance the drug’s absorption in the body.

While Merck also pursues a subcutaneous version of Keytruda, their longer-term focus centers on a version containing the enzyme hyaluronidase, allowing for dosing every six weeks. This candidate is expected to have phase 1 results by 2026.

Halozyme’s Enhanze technology extends beyond Roche’s Tecentriq, as it is also utilized in Roche’s proposed subcutaneous formulation of the blockbuster multiple sclerosis antibody, Ocrevus. Promising results in patients with relapsing forms of MS or primary progressive MS were reported in the phase 3 OCARINA II trial. Roche intends to submit these results to regulators worldwide this year.

In June, the FDA cleared Argenx’s subcutaneous Vyvgart for the treatment of generalized myasthenia gravis, another product leveraging Halozyme’s Enhanze technology. This product also experienced a three-month delay in its FDA review.

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