TECENTRIQ® (atezolizumab) - Risk of Immune-Related Myositis

Starting date:
March 13, 2019
Posting date:
March 13, 2019
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-69274

 

Audiences

 

Healthcare professionals including: oncologists, pulmonologists/respirologists, uro-oncologists, urologists, emergency department staff (physicians, pharmacists, nurses), oncology nurses, oncology pharmacists, and other healthcare professionals providing care to cancer patients, including those working in hospitals, cancer centers, oncology clinics and pharmacies, as well as primary care physicians, cardiologists, rheumatologists and / or neurologists.

 

Key messages

 

  • Cases of immune-related myositis, some with a fatal outcome, have been reported in patients receiving TECENTRIQ (atezolizumab). 
  • Healthcare professionals are advised to:
    • Hold TECENTRIQ treatment in patients with moderate or severe (Grade 2 or 3) immune-related myositis until symptoms resolve.
    • Permanently discontinue TECENTRIQ treatment in patients with recurrent, severe, or life-threatening myositis (recurrent Grade 3 and Grade 4).
    • Administer corticosteroids (1-2 mg/kg intravenous methylprednisolone or equivalent per day) to patients who develop severe signs of myositis, such as weakness limiting mobility, respiratory function, or dysphagia.
    • For patients with severe or life-threatening myositis (Grade 3 and Grade 4) who do not improve following corticosteroid therapy, consider administration of other immunosuppressive agents as described in  the American Society of Clinical Oncology Clinical Practice Guideline (http://ascopubs.org/doi/full/10.1200/JCO.2017.77.6385)
  • Health Canada is working with the manufacturer to include the risk of immune-related myositis in the Canadian Product Monograph for TECENTRIQ. 

             

Issue

As of February 4, 2019, 51 serious and 14 non-serious cases of immune-related myositis have been reported in patients receiving TECENTRIQ treatment including, 4 with a fatal outcome. There were no Canadian cases reported.

 

Products affected

 

TECENTRIQ (atezolizumab) concentrate for solution for infusion, 60 mg / mL in 20 mL single use vials.

 

Background information

 

TECENTRIQ has received market authorization in Canada for use in the following clinical settings:

1. Locally Advanced or Metastatic Urothelial Carcinoma
TECENTRIQ has been issued marketing authorization with conditions, meaning that conditions apply, pending the results of studies to verify its clinical benefit for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • have disease progression during or following platinum-containing chemotherapy; or
  • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy.

2. Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
TECENTRIQ has been issued marketing authorization for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Patients with EGFR or ALK genomic tumour aberrations should have disease progression on a therapy for these aberrations prior to receiving TECENTRIQ.

Myositis or inflammatory myopathies are a group of disorders sharing the common feature of inflammatory muscle injury. Dermatomyositis and polymyositis are among the most common disorders. Diagnosis is based on clinical (muscle weakness, muscle pain, skin rash in dermatomyositis), biochemical (serum creatine-kinase increase), and imaging (electromyography/MRI) features, and is confirmed with a muscle-biopsy.

As of February 4, 2019, a comprehensive analysis was performed across the TECENTRIQ program and identified 51 serious and 14 non-serious cases of immune-related myositis.  Of the identified serious and non-serious cases, 53 were from clinical trials and 12 from post-marketing. Of the 53 clinical trial cases, 5 were identified as category A confirmed with a muscle biopsy. There were no Canadian cases reported. Approximately 19,323 clinical trial patients and 28,975 post-marketing patients have been exposed to TECENTRIQ as of Nov 17, 2018. The incidence of myositis (including related terms of dermatomyositis, polymyositis, rhabdomyolysis) observed across the atezolizumab monotherapy clinical program was <0.1%. Based on the assessment of all available data, immune-related myositis is considered an important identified risk for TECENTRIQ.

Who is affected

 

Information for consumers

 

TECENTRIQ is used to treat a type of bladder cancer called urothelial carcinoma that cannot be removed by surgery or has spread to other parts of the body. TECENTRIQ is used after platinum-based chemotherapy has been tried and did not work or is no longer working.

TECENTRIQ is also used to treat a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body. TECENTRIQ is used after platinum-based chemotherapy has been tried and did not work or is no longer working.

TECENTRIQ has been associated with the risk of developing immune-related myositis in some patients. Immune-related myositis is a type of inflammation of the muscles used to move your body. It can cause muscle weakness and muscle pain and may lead to difficulty moving, breathing, and /or swallowing.

Patients receiving TECENTRIQ should inform their healthcare professional if they experience these or any other side effects.

Patients should contact their healthcare professional to obtain further information on this new safety information.

 

Information for healthcare professionals

 

  • Hold treatment in patients with moderate or severe (Grade 2 or 3) immune-related myositis until symptoms resolve.
  • Permanently discontinue TECENTRIQ treatment in patients with recurrent, severe, or life-threatening myositis (recurrent Grade 3 and Grade 4).
  • Administer corticosteroids (1-2 mg/kg intravenous methylprednisolone or equivalent per day) to patients who develop severe signs of myositis, such as weakness limiting mobility, respiratory function, or dysphagia.
  • For patients with severe or life-threatening myositis (Grade 3 and Grade 4) who do not improve following corticosteroid therapy, consider administration of other immunosuppressive agents as described in the American Society of Clinical Oncology Clinical Practice Guideline (http://ascopubs.org/doi/full/10.1200/JCO.2017.77.6385)

 

Action taken by Health Canada

 

Health Canada, in collaboration with Hoffmann-La Roche Limited, is updating the TECENTRIQ Product Monograph to include information related to the risk of immune-related myositis. Health Canada is also communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of immune-related myositis or other serious or unexpected side effects in patients receiving TECENTRIQ should be reported to Hoffmann-La Roche Limited or Health Canada.

Hoffmann-La Roche Limited
Drug Safety Department
7070 Mississauga Road
Mississauga, Ontario, L5N 5M8
Toll free: 1-888-762-4388
Fax: 905-542-5864
E-mail: mississauga.drug_safety@roche.com

To correct your mailing address or fax number, contact Hoffmann-La Roche Limited.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738