Better late than never for FDA approval of the first subcutaneous PD-L1 inhibitor—Roche’s TECENTRIQ HYBREZA—after manufacturing delays disrupted the company’s initial launch plans last year.
The FDA was originally set to decide on TECENTRIQ’s under-the-skin formulation in September, but Roche’s delivery technology partner, Halozyme Therapeutics, noted that updates to the drug’s manufacturing processes were required. According to Roche, these adjustments were made to meet the FDA’s evolving requirements and were expected to be completed in 2023 to enable a 2024 launch. The formulation received its first approval in the UK last year.
On 13 September 2024, the FDA ...
