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# Subcutaneous Tecentrig Delayed Due to CMC Info
- URL: https://www.fdaweb.com/subcutaneous-tecentrig-delayed-due-to-cmc-info/
- Published: 2023-09-08T12:00:00.000Z
- Updated: 2026-09-14T18:55:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155283

Roche’s Genentech will not be getting FDA approval this month for a subcutaneous formulation of its lung cancer drug Tecentriq (atezolizumab) after the agency requested that the company update the chemistry, manufacturing and controls (CMC) information in the supplemental BLA submission. The approval delay was revealed in a financial filing by Halozyme Therapeutics, Genentech collaboration and license partner. The subcutaneous formulation was developed using Halozyme’s ENHANZE drug delivery technology.

Halozyme says the technology is based on its recombinant human hyaluronidase PH20 enzyme, rHuPH20, which locally degrades hyaluronan in the subcutaneous space temporarily removing a barrier to fluid flow. “Large volume injections may allow some biologics and small molecule drugs that are administered intravenously to be delivered subcutaneously, opening the door to potential benefits for patients, healthcare systems and manufacturers,” it says.

Halozyme says that Roche told it that the CMC information will be updated later this year, with a projected product launch now pushed back until next year.