Tumour-agnostic cancer treatment now available in Aus
A medicine to treat cancer based on the genetic profile of the tumour, rather than tumour type or location, has now been registered on the Australian Register of Therapeutic Goods (ARTG), marking what is believed to be the first ‘tumour agnostic’ approach to cancer treatment in Australia.
Global biopharmaceutical company MSD has confirmed that its PD-1 inhibitor, KEYTRUDA, can now be used to treat eligible patients whose cancer has a specific genetic alteration (a biomarker) called deficient DNA-mismatch repair (dMMR) or microsatellite instability-high (MSI-H). These patients must have advanced cancer (where the cancer has spread to other organs) that has progressed following prior treatment and have no satisfactory alternative treatment options.
KEYTRUDA works to reactivate the immune system to attack cancer cells by blocking a specific protein (known as PD-1 or programmed cell death protein), which left unchecked allows cancer cells to pass undetected by the body’s natural defences. It is currently only PBS-listed for eligible Australians with unresectable or malignant melanoma, refractory or relapsed classical Hodgkin lymphoma, previously untreated metastatic non-small cell lung cancer, and locally advanced or metastatic urothelial cancer.
Colorectal cancer is just one form of cancer that can display the dMMR and/or MSI- H biomarker, and the new indication specifically identifies advanced colorectal cancer patients with this biomarker, whose disease has progressed following treatment with multiple therapies, as eligible for treatment. This indication was approved under the provisional approval pathway, which provides a six-year window to collect further data to support KEYTRUDA’s use in microsatellite instability-high cancer and to transition to a full registration.
It is estimated that there are more than 20 different tumour types that may display MSI-H and/or dMMR, which can be identified through laboratory tests. These tumours include colorectal, endometrial, gastric, small intestinal, pancreatic, cholangiocarcinoma, adrenocortical, mesothelioma, small-cell lung, cervical, neuroendocrine, thyroid, urothelial, brain, ovarian, prostate, retroperitoneal, salivary, sarcoma, testicular and tonsillar cancers.
“This is the first tumour-agnostic indication made available in Australia,” said Michael Azrak, Managing Director of MSD Australia. “It marks a shift in treating cancer according to the genetic type of the tumour as opposed to the tumour location.
“It represents a new way in which some cancers will be treated in Australia and is an important step in precision medicine.”
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