FDA Approves Subcutaneous Tecentriq to Treat Multiple Cancers

The FDA has approved Genentech’s Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first PD-(L)1 inhibitor for subcutaneous (SC) administration. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30 minutes to 60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab). Genentech is a member of the Roche Group.

“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation, said in a news release. “When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option.”

Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology. Tecentriq Hybreza will be available in a few weeks and be priced at parity with the IV Tecentriq 1200 mg vial.

Tecentriq is available to treat patients with early-stage non-small-cell lung cancer, small cell lung cancer and hepatocellular carcinoma. It is a monoclonal antibody designed to bind with PD-L1 that is expressed on tumor cells and tumor-infiltrating immune cells. This enables the reactivation of T cells.

The cost of Tecentriq 840 mg/14 mL intravenous is around $8,062, and the cost of Tecentriq 1200 mg/20 mL is 11,512.57, according to Drugs.com.

Genentech offers a $0 copay assistance program for eligible patients with commercial insurance with a limit of $25,000 a year. The terms of the program say that Genentech may cap the assistance if “Genentech determines that a third party has implemented a program that adjusts patient cost-sharing obligations based on the availability of support under the Program and/or excludes the assistance provided under the program from counting towards the patient’s deductible or out-of-pocket cost limitations.”

The approval of Tecentriq Hybreza was based on data from the phase 1b/3 IMscin001 study, which enrolled 371 patients and showed comparable levels of Tecentriq in the blood, when administered subcutaneously. The safety and efficacy profile were consistent with the IV formulation.

The phase 2 IMscin002 study enrolled 179 patients and showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab. The most common reasons were less time in the clinic, increased comfort during treatment and reduced emotional distress.