Lapse of provisional registration for Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic triple negative breast cancer (mTNBC)

On 22 March 2023, the provisional registration of Tecentriq (atezolizumab) for the treatment of mTNBC will lapse - this means that Tecentriq will no longer be approved for this use.

There are no changes to the other approved indications of Tecentriq^[1].

The decision to provisionally approve Tecentriq (atezolizumab) for mTNBC was based on promising results from the IMpassion 130^[2] study. It was expected that data from the IMpassion 131^[3] study would confirm the results.

Data from the IMpassion 131 study did not confirm the results, so it did not support transition to full registration. The medicine sponsor, Roche, in consultation with the TGA, has voluntarily withdrawn its application to convert the provisional registration for mTNBC to full registration.

A summary of the application, including advice from the Advisory Committee on Medicines, is available in the Australian Public Assessment Report. Further information on the provisional pathway is also on our website.

Information for consumers

• There are no new safety concerns for Tecentriq.
• This does not affect any other approved indication for Tecentriq in Australia. Patients taking Tecentriq for other approved indications should continue to take their medication as directed by their health care professional
• Roche has informed the TGA that the first-line mTNBC Tecentriq Patient Access Pathway program will close. Roche will provide further information about this directly to health care professionals.
• The TGA strongly encourages patients to speak to their doctor about the above, including to discuss future treatment options.

Roche can be contacted via its Medical information team for further information on: 1800 233 950 or www.medinfo.roche.com/australia

What is provisional registration?

The provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines, or new uses of existing medications, with preliminary clinical data. The decision to provisionally register a medicine means that the TGA has assessed that the benefit of early availability outweighs the risk that additional data are still required.

Provisional registration is limited to a maximum of six years. Sponsors may apply for full registration once they believe sufficient clinical data are available to confirm the safety and efficacy of the medicine/new use. However, if sufficient data can’t be supplied, then the provisional registration will lapse at the end of the specified period.