Sept. 18, 2024 – The FDA has approved an injectable form of the cancer drug atezolizumab in combination with the enzyme hyaluronidase for use in patients with certain types of cancers of the lung, liver, skin, and soft tissues. It offers an easier-to-use and less time-consuming alternative to the currently available form of the drug.
The combination works by helping the body's immune system identify and attack cancer cells. It targets PD-L1, a protein that normally helps cancer cells hide from the immune system. Hyaluronidase makes it easier for atezolizumab to be absorbed when injected under the skin. The new drug will be marketed under the brand name Tecentriq Hybreza.
In approving the new treatment method, the FDA cited clinical studies that showed comparable levels of atezolizumab in the blood when injected beneath the skin and a safety and efficacy profile comparable with that of the standard intravenous treatment. The FDA said the injectable form can be administered in about 7 minutes, every 3 weeks. That compares to about 30 minutes to 60 minutes treatment time for the current infusion method. The common side effects included fatigue, muscle and bone pain, cough, shortness of breath, and decreased appetite.
Genentech, the drug’s manufacturer, said in a press release that a clinical trial found that 71% of patients preferred the improved ease of use of Tecentriq Hybreza to intravenous atezolizumab because it required less time spent in a clinic, provided greater comfort, and reduced emotional distress. The approval marks Tecentriq Hybreza as the first anti-PD-(L)-1 cancer immunotherapy drug available as a subcutaneous injection.
The injectable form of the cancer immunotherapy drug "offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration," said Levi Garraway, MD, PhD, Genentech's chief medical officer and head of global product development, in a press release.
