- Advertisement -
- Advertisement -
- Advertisement -

Find a job

Subscribe for free

All things Pharma

MHRA approves Roche’s subcutaneous cancer immunotherapy

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Roche’s Tecentriq® SC (atezolizumab), the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes.

Injecting Tecentriq subcutaneously takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq SC will be available to patients in Great Britain for all indications in which the IV formulation of Tecentriq has been previously approved, including certain types of lung, bladder, breast and liver cancer.2

Tecentriq SC is Roche’s fourth subcutaneous cancer therapy.3-5 Multiple oncology studies suggest that the majority of cancer patients generally prefer SC over IV administration due to reduced discomfort, ease of administration and shorter duration of treatment.6-10

The MHRA regulatory approval is the first for Tecentriq SC worldwide. It 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.11

For Northern Ireland, the Tecentriq SC marketing authorisation application is currently under assessment by the European Medicines Agency (EMA). Evaluations by the US Food and Drug Administration (FDA) and other health authorities globally are also ongoing.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said: “Cancer immunotherapy has transformed the way we treat cancer. 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. We are working with health authorities globally to bring this option to many more patients around the world.”

References

1 Anderson, K C, et al. Humanistic and economic impact of subcutaneous versus intravenous administration of oncology biologics. Future Oncol. 2019;15(28):3267-3281.

2 UK Electronic Medicines Compendium (EMC). Tecentriq: package leaflet. Last updated 5 July 2022. https://www.medicines.org.uk/emc/files/pil.8442.pdf Accessed April 2023.

3 UK EMC. Phesgo SC: package leaflet. Last updated 16 March 2022. https://www.medicines.org.uk/emc/files/pil.11989.pdf Accessed April 2023.

4 UK EMC. Herceptin SC: package leaflet. Last updated 28 September 2021. https://www.medicines.org.uk/emc/files/pil.1227.pdf Accessed April 2023.

5 UK EMC. MabThera: package leaflet. Last updated 24 January 2022. https://www.medicines.org.uk/emc/files/pil.5333.pdf Accessed April 2023.

6 De Cock E, et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016;5(3):389-97.

7 O’Shaugnessy, J. Patient (pt) preference for the pertuzumab-trastuzumab fixed-dose combination for subcutaneous use (PH FDC SC) in HER2-positive early breast cancer (EBC): Primary analysis of the open-label, randomised crossover PHranceSCa study. Presented at ESMO; 19-21 Sept 2020. Abstract #165MO.

8 Pivot X, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017;86:82-90

9 Rummel M, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.

10 Denys H, et al. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020;181(1):97-105.

- Advertisement -
Emma Cooper
Emma Cooper
Emma is Content Manager at Pf Media.

MORE FROM AUTHOR

- Advertisement -

LATEST POSTS

Subscribe

Sign up to receive our digital newsletter, for all the essential headlines, Jobs of the Week and thought-provoking features.

Claim my free subscription