Roche has received FDA approval for subcutaneously injectable versions of two biologic drugs—Tecentriq Hybreza for cancer and Ocrevus Zunovo for multiple sclerosis. These new formulations offer a faster administration time compared to traditional infusions, allowing Tecentriq to be injected in just seven minutes and Ocrevus Zunovo in 10 minutes. This is a significant reduction compared to the infusion times, which can take up to an hour for Tecentriq and two hours for Ocrevus.
Tecentriq Hybreza's approval is based on a study showing that its efficacy is comparable to the IV version, with side effects like fatigue and musculoskeletal pain. The new formulation is available for the same cancer indications as the original drug, including lung cancer and melanoma. It is approved in over 50 countries and is marketed as Tecentriq SC outside the U.S.
Similarly, Ocrevus Zunovo was approved following a Phase 3 study comparing it to the infused version, with no significant differences in safety or efficacy. Ocrevus Zunovo is administered every six months, offering patients with relapsing or progressive MS a more convenient alternative to lengthy infusions. Both drugs use Halozyme Therapeutics' Enhanze technology to enable rapid subcutaneous administration.
Click here to read the original news story.