International collaboration approves anti-uterine cancer duo

Australian women will be among the first in the world to access a new combination therapy on private prescription for the most common form of uterine cancer.

 This follows a world-first collaboration between regulators in Australia, the US and Canada.

The simultaneous registration means that MSD’s anti-PD-1 immunotherapy Keytruda (pembrolizumab) can be prescribed in combination with Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) to treat eligible women with a certain type of advanced endometrial cancer who experienced progression after previous systemic therapy and are not candidates for surgery or radiation.

These medicines are not listed on the PBS for endometrial cancer.

The combination therapy was fast-tracked in Australia and registered within four months of regulatory submission under a provisional pathway that forms part of Australia’s commitment to streamline processes by collaborating with overseas regulators, including the Food and Drug Administration (FDA) in the US.

Managing Director for MSD in Australia Michael Azrak said, “This new indication demonstrates our commitment to explore all avenues for this immuno-oncology medicine.

“We are committed to working with the federal government to make this treatment combination available on the PBS for eligible endometrial cancer patients.”

Endometrial cancer, which is a cancer of the lining of the uterus, is the most common gynaecological cancer. Each year, more than 2,500 Australian women are diagnosed with endometrial cancer and around 500 women die.

MSD is collaborating with Eisai to investigate the use of Keytruda with Lenvima in clinical trials. This is the first approval to result from the international collaboration.


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