Thursday 20 September 2018

Drug that shrank Vicky's tumour should be made available to all - leading oncologists

Vicky Phelan has seen and felt a big improvement after just three doses of the drug. Photo: Steve Humphreys
Vicky Phelan has seen and felt a big improvement after just three doses of the drug. Photo: Steve Humphreys
Eilish O'Regan

Eilish O'Regan

Two leading oncologists are calling for wider access to a drug which cervical cancer sufferer Vicky Phelan revealed had reduced her tumours.

Ms Phelan, the Limerick mother-of-two who exposed the CervicalCheck scandal, announced the "significant shrinkage" in tumours this week after treatment with the drug pembrolizumab.

Dr. David Fennelly wants more cervical cancer sufferers to access pembrolizumab following the experience of Vicky Phelan. Photo: Damien Eagers
Dr. David Fennelly wants more cervical cancer sufferers to access pembrolizumab following the experience of Vicky Phelan. Photo: Damien Eagers

She was diagnosed with cervical cancer in 2014 after receiving an incorrect smear test result in 2011.

Her specialist Dr David Fennelly of St Vincent's Hospital and his colleague John Crown now want more women with cervical cancer, and who have been assessed as being potentially suitable for the treatment, to have access to the drug.

It is not covered by the HSE and is expensive, costing around €5,000 to €6,000 a treatment.

And it is currently not licensed in Europe for cervical cancer, although it is used in the treatment of other forms of the disease such as melanoma, kidney and lung cancer.

Vicky Phelan. Photo: Fergal Phillips
Vicky Phelan. Photo: Fergal Phillips

Dr Fennelly told the Irish Independent he was anxious to set up a phase two drug trial here to speed up the availability of the treatment to more women with cervical cancer.

"There is going to be huge pressure to get access to the drug but under the normal regulatory mechanisms it could take three years and that is too long," he said.

Although women among the group of 209 at the centre of the CervicalCheck scandal will be given the drug, other patients with the same disease are having to fundraise or borrow in an attempt to try to purchase it because the HSE will not reimburse the cost.

The drug, made by Merck, works through a form of immunotherapy in which medication helps the patient's own immune system to attack cancerous cells while leaving healthy cells unharmed.

Dr Fennelly said patients whose tumours display the protein PD-L1 are potentially the most likely to respond to the treatment.

A phase two drug trial would test the drug on a large group of women.

Depending on the results that could make it available more quickly than waiting for a phase three trial where it is compared to conventional treatment.

"The difficulty is that it is very expensive. It can cost €5,000 to €6,000 per treatment. A patient can need several treatments before they see an improvement," said Dr Fennelly.

"I have spoken to the pharmaceutical company and I am trying to design drugs trials."

Around 150 to 200 women whose cancer has spread and who have very few other options could potentially benefit.

One of the upsides of the drug is that it does not have the side effects of more conventional treatment.

Other patients who have sarcoma, a cancer that affects the tissues that connect, support and surround other body structures and organs, are also seeking wider access.

"Some of the patients I am seeing tend to have very few other options," Dr Fennelly added.

The drug has been licensed for use in cervical cancer patients by the Food and Drug Administration in the United States on the basis of phase two drug trials.

The HSE said yesterday an expert group in the European Medicines Agency on June 1 made recommendations for market authorisation of pembrolizumab to be extended for certain cancers around the bladder region and this remains under consideration. Its use is a matter between the patient and her doctor.

Irish Independent

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