Roche’s subcutaneous Tecentriq wins approval Great Britain approval weeks ahead of expected US decision

Patients in Great Britain who take IV Tecentriq now have a quicker option.

The country’s regulatory authority has approved a subcutaneous version of atezolizumab, better known as Roche’s blockbuster immunotherapy Tecentriq. The new version takes just seven minutes to administer, as opposed to 30 to 60 minutes for the IV formulation, Roche announced on Tuesday.

The news comes weeks ahead of an expected decision in the US on Sept. 15, executives said on the company’s recent Q2 earnings call per an AlphaSense transcript. In Great Britain, Tecentriq SC’s label covers all the same indications as the IV formulation and will be available “in the coming weeks,” a spokesperson told Endpoints News. The EU’s regulatory authority is currently considering the drug’s use, including in Northern Ireland.

Tecentriq SC’s approval marks its first worldwide, and the first subcutaneous PD-L1 approval in Great Britain, Roche said. The checkpoint inhibitor was first approved in the US in 2016 for certain metastatic lung cancer patients, and has since expanded to a variety of cancers, including bladder, breast and liver cancer. The drug generated roughly $4.2 billion in 2022 sales, representing Roche’s fourth-highest seller.

Levi Garraway

“Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile,” Roche’s CMO and head of global product development Levi Garraway said in a news release.

Rival drugmakers are also working on subcutaneous versions of their blockbuster PD-L1s, including Merck, which recently announced its Keytruda SC candidate met the co-primary endpoints in an ongoing Phase III trial in certain non-small cell lung cancer patients. Bristol Myers Squibb’s subcutaneous version of Opdivo is currently in Phase III.

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