Roche Submits NDA in China for Subcutaneous PD-L1 Inhibitor Atezolizumab, Reducing Treatment Time to 4–8 Minutes

Jul 27, 2024 08:03 CST Updated 08:04

Roche

Oncology Drug Research, Development, and Manufacturing

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Today (July 27), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Applied by RocheAtezolizumab Injection (Subcutaneous Injection)The listing application has been accepted.Public information shows that Atezolizumab is a PD-L1 inhibitor, which has been approved for multiple indications worldwide. The product submitted for marketing approval this time is its subcutaneous injection formulation.According to the introduction in Roche's previously published press release,Subcutaneous AdministrationAtezolizumabEach injection can reduce the treatment time to 4-8 minutes (usually 7 minutes), while standard intravenous infusion takes 30-60 minutes.。

Atezolizumab (Tecentriq）It is a monoclonal antibody targeting PD-L1 developed by Roche. The drug has been approved globally for the treatment of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma, urothelial carcinoma, PD-L1 positive metastatic triple-negative breast cancer, andBRAF V600Mutations in various cancers such as advanced melanoma. In China, it was approved in 2020 as a first-line treatment for extensive-stage small cell lung cancer.

According to an earlier press release from Roche,AtezolizumabSubcutaneous Formulations WillAtezolizumabCombined with Halozyme Therapeutics' Enhanze drug delivery technology。Enhanze drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20）`, which can temporarily degrade hyaluronic acid in the human body.`，TherebySubcutaneous formulations can disperse and be absorbed into the bloodstream quickly.

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, Roche is conducting an international multicenter (including China) Phase 1b/3 clinical study (IMscin001 study), aiming toPatients with locally advanced or metastatic non-small cell lung cancer who have been previously treatedResearch in ChinaSubcutaneous InjectionAtezolizumab compared toIntravenous InjectionPharmacokinetics, Efficacy, and Safety of Atezolizumab.

The subjects of the study wereLocally advanced or metastatic non-small cell lung cancer that has not been exposed to cancer immunotherapy (CIT) (i.e., CIT-naive) and has failed prior treatment with platinum-based therapy.Patients. In the study, the administration method of Atezolizumab Injection was subcutaneous injection, once every three weeks. The study plans to enroll 58 participants in China, with 371 participants already enrolled internationally.

Roche previously announced that the IMscin001 study had achieved its co-Primary Endpoint. The study shows that, in patients who have not received cancer immunotherapyLocally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based TherapyIn patients, compared with intravenous (IV) infusion, subcutaneous injectionAtezolizumabThe level in the blood (pharmacokinetics) demonstrated non-inferiority.

In August 2023, Roche announced,Based onPhase 1b/3 Clinical Study IMscin001Subcutaneous InjectionAtezolizumabApproved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing, used forAtezolizumabInjectable FormulationsAll previously approved indications (including certain types of lung cancer, bladder cancer, breast cancer, and liver cancer). This approval isSubcutaneous InjectionAtezolizumabFirst approved by regulatory authorities worldwide. In November 2023, Roche announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (CHMP）Recommend Approval for Subcutaneous InjectionAtezolizumab Marketing Application,Used for previously approvedAtezolizumab Intravenous InjectionAll indications.

This time,Subcutaneous InjectionThe submission of atezolizumab for marketing authorization in China indicates that the subcutaneous formulation of this product is also expected to benefit Chinese patients in the near future.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Jul 27, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types. Retrieved Nov 14 2023, from https://www.globenewswire.com/news-release/2023/11/14/2779693/0/en/Roche-s-subcutaneous-injection-of-Tecentriq-recommended-by-the-EU-s-CHMP-for-multiple-cancer-types.html

[3]Roche’s subcutaneous formulation of Tecentriq demonstrates positive Phase III results. Retrieved Aug 2, 2022, from https://www.roche.com/media/releases/med-cor-2022-08-02

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