17
Jul
2019

Keytruda receives provisional approval

Bowel Cancer Australia

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Australia's Therapeutic Goods Administration (TGA) has today given Keytruda® (pembrolizumab) provisional approval for patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) bowel cancer.

Bowel Cancer Australia's Bowel Care Nurses first began receiving calls two years ago from metastatic bowel cancer patients and loved ones regarding the availability of Keytruda in Australia, following its approval by the US Food & Drug Administration (FDA).

“While there is a lot of important discussion regarding bowel cancer screening, treatment options remain vital,” said Bowel Cancer Australia Chief Executive Julien Wiggins.

Only 13.4% of metastatic bowel cancer patients survive five years after diagnosis.

“Having another treatment option for metastatic bowel cancer patients is much needed."

MSI-H and dMMR tumours contain abnormalities that affect the proper repair of DNA inside the cell. Tumours with these biomarkers are most commonly found in bowel, endometrial and gastrointestinal cancers.

Approximately five percent of patients with metastatic bowel cancer have MSI-H or dMMR tumours.

While Bowel Cancer Australia welcomes today’s announcement, for more patients to benefit from this treatment option it must become affordable through listing on the Pharmaceutical Benefits Scheme (PBS) as a subsidised treatment.

According to the TGA announcement, the continued approval of Keytruda for the new indication will depend on further evidence of clinical benefit from clinical trials.


Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells).

By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells, which is why the treatment is referred to as ‘immunotherapy’. 

Keytruda is given as an intravenous (IV) infusion. Treatment takes about 30 minutes and is given every 3 weeks.


As with all treatment options, people interested in accessing the treatment will need to discuss Keytruda with their oncologist. 

It is currently not available as a subsidised treatment on the Pharmaceutical Benefits Scheme (PBS).

For more information, you can check the Consumer Medicines Information (CMI)

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