Swiss drug major Roche Holding AG (RHHBY) announced Tuesday that the European Medicines Agency’s Committee for Medicinal Products for Human Use or CHMP has recommended the approval of Tecentriq (atezolizumab) subcutaneous or SC, i.e., under the skin injection.
The CHMP has recommended Tecentriq SC for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder and breast cancer. The company expects a final decision on its approval from the European Commission in the near future.
Tecentriq SC combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology. It is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 or PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
Roche noted that the CHMP’s positive opinion is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.
According to the company, Tecentriq SC can be injected in around seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous or IV infusion. This helps patients, healthcare teams and caregivers to free up time.
If approved, Tecentriq SC would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by around 80%.
Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, said, “Subcutaneous administration offers a faster and more convenient alternative to IV infusion. The CHMP’s recommendation brings us a step closer to offering the first subcutaneous PD-L1 cancer immunotherapy treatment to patients in the EU.”
Tecentriq SC recently received its first marketing authorisation in Great Britain.
Tecentriq is approved for some of the most aggressive and difficult-to-treat forms of cancer. It was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC).
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