Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)

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In Malaysia, Tecentriq® (atezolizumab) is approved for the treatment of non-small cell lung cancer, small cell lung cancer and triple-negative breast cancer.

Based on a cumulative analysis on the company’s global safety database across the atezolizumab clinical development programme, 99 cases of severe cutaneous adverse reactions (SCARs) have been identified, of which 36 SCARs cases were confirmed by either histopathology or specialist diagnosis in patients whom had received atezolizumab. SCARs include acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS).

Up to 17th May 2020, approximately 23,654 clinical trial patients and 106,316 patients in post-marketing settings have been exposed to Tecentriq®. The incidence rates of SCAR (regardless of severity) from pooled atezolizumab monotherapy and combination therapy were 0.7% and 0.6%, respectively.

The Malaysian product information (PI) of Tecentriq® has been updated with information pertaining to this newly identified risk. Please refer to the latest approved PI for detailed information on SCARs.

On 26th January 2021, NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.

 

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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