Roche's Tecentriq Hybreza wins first FDA approval for subcutaneous PD-L1 drug after delay

The Food and Drug Administration (FDA) has granted approval to Roche’s Tecentriq Hybreza, a subcutaneous PD-L1 inhibitor, marking a significant milestone in cancer therapy. This approval comes after a year-long delay caused by the need for manufacturing revisions. Originally scheduled for a decision in September of the previous year, the process was derailed due to the necessity of updating manufacturing practices. Halozyme Therapeutics, Roche’s partner in delivery technology, announced that these updates were made to align with the FDA's evolving requirements and were anticipated to conclude by 2023 to facilitate a 2024 launch.

Tecentriq Hybreza's approval in the U.S. follows its world-first approval in the U.K. last year and applies to all adult indications of the Tecentriq formulation, including various types of lung, liver, skin, and soft tissue cancers. This new version of the drug employs Halozyme’s Enhanze technology, enabling subcutaneous injection over seven minutes, a significant improvement over the traditional intravenous (IV) infusion, which can take between 30 to 60 minutes.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, highlighted the advantages of this new administration method. "By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration," Garraway stated in a press release.

A phase 2 study demonstrated a strong preference for the subcutaneous version among patients, with 71% favoring it over the standard formulation. Participants cited increased comfort, reduced time spent in the clinic, and lower emotional distress as key factors for their preference. Furthermore, 79% of patients who experienced both formulations chose to continue with Tecentriq Hybreza.

The Enhanze technology, used in Tecentriq Hybreza, is based on a proprietary recombinant human hyaluronidase enzyme. This technology enhances the dispersion and absorption of the therapy into the bloodstream, facilitating quicker and easier administration. Enhanze has also improved delivery for other major cancer treatments, including Johnson & Johnson’s Darzalex Faspro and potentially Bristol Myers Squibb’s Opdivo, although the latter has not yet received approval for subcutaneous use.

While Tecentriq Hybreza is the first subcutaneous checkpoint inhibitor approved by the FDA, Bristol Myers Squibb's Opdivo is also expected to receive a verdict for its subcutaneous version later this year. Tecentriq initially received approval in 2016 and achieved CHF 3.77 billion ($4.44 billion) in sales in 2023. Despite facing competition from notable rivals like Merck’s Keytruda in the non-small cell lung cancer (NSCLC) market, Roche's pharmaceutical division, led by Teresa Graham, remains confident in their standing. "We are still holding our own in the U.S.," stated Graham during a conference call in February.

In summary, the FDA's approval of Tecentriq Hybreza introduces a more patient-friendly administration method for multiple cancer types, offering increased comfort and convenience. This approval not only enhances the treatment landscape for cancer patients but also underscores Roche's ongoing commitment to innovation in oncology.