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FDA Approves Roche's Groundbreaking 7-Minute Cancer Immunotherapy Injection

Swiss pharmaceutical giant, Roche has announced that the FDA has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), representing a significant advancement in cancer immunotherapy. Tecentriq Hybreza, the first subcutaneous (SC) PD-(L)1 inhibitor, provides a faster and more convenient alternative to intravenous (IV) dosing for patients in the United States. Tecentriq IV typically takes 30 to 60 minutes to infuse, whereas the new SC form may be injected in around seven minutes. 

This approval permits the use of Tecentriq Hybreza for all IV indications approved for adult patients, such as lung, liver, and skin malignancies. Dr. Levi Garraway, Roche's Chief Medical Officer, stated that "by enabling subcutaneous administration for cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration." This SC formulation's convenience may greatly benefit cancer patients by providing quicker treatment times and more convenient administration locations.

The FDA granted approval based on key data from the Phase IB/III IMscin001 and Phase II IMscin002 investigations. The IMscin001 trial found that Tecentriq Hybreza had the same efficacy and safety profile as the IV formulation, whereas the IMscin002 study found that 71% of patients preferred Tecentriq Hybreza because it required less time in the clinic and provided more comfort during treatment. Ann Fish-Steagall, RN, of the LUNGevity Foundation, stated, "This clearance represents a huge opportunity to improve the patient experience... When patients have options, they feel empowered to take an active role in their own care." 

Roche's commitment to enhancing patient experiences is evident in its introduction of subcutaneous medicines, which includes its latest product, Tecentriq Hybreza. In August 2023, Great Britain granted Tecentriq Hybreza its first global approval, and it currently holds approval in 50 countries.

The advent of subcutaneous Tecentriq is a watershed moment in immunotherapy, providing cancer patients greater control over their treatment options while maintaining the efficacy and safety of traditional intravenous techniques.


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