This was published 7 years ago
TGA approves new lung cancer drug osimertinib for patients dealt cruel double blow
Elly Calabia doesn't talk about survival rates and life expectancy with her oncologist. Instead, she's thinking of her next home renovation and the lunch she'll cook for her family for Christmas.
"I'll cook ham," Mrs Calabia, 54, said from her Ingleburn home, surrounded by Christmas decorations.
She knows the non-small cell lung cancer (NSCLC) she was diagnosed with two years ago has spread to her stomach and brain. She knows her tumours have developed a resistance to treatment.
"I don't want to know [how long I might have to live]. If I can live longer, I will," she said.
Elly Calabia, who has cancer, in her Sydney home. Credit: Janie Barrett
A routine X-ray before eye surgery in 2014 revealed the dark grey mass on her right lung. "It was like a bomb hit [me]," Mrs Calabia, who smoked until 12 years ago, said.
"I just really couldn't believe it: I have cancer. It was just a problem with my eye. I had no symptoms, no pain and then suddenly I get the worst news."
Then came the next blow. In September Mrs Calabia tested positive for an epidermal growth factor receptor mutation – a protein involved in the growth and spread of cancer cells – resistant to treatment.
NSCLC patients who have an EGFR mutation are usually treated with a type of targeted cancer therapy called EGFR-Tyrosine Kinase Inhibitors (TKIs), which muddle the signals that cause the tumour cells to grow.
But between half and two-thirds of those patients, whose cancer continues to grow after being treated with TKIs, are dealt another devastating setback; they develop a resistant mutation known as T790M.
Mrs Calabia is one of those patients.
"We tried so many medications and they would stop working after a couple of months ... the cancer kept growing," she said.
Lung cancer is the biggest cancer killer in Australia, accounting for 18.8 per cent of all cancer deaths in 2016 . An estimated 8839 people will die of the disease this year, according to Cancer Council Australia.
The chance of surviving lung cancer past five years is 15 per cent.
The Therapeutics Goods Administration announced on Thursday that it had approved a new TKI, osimertinib (Tagrisso), to treat patients with this specific mutation.
Drug trials have shown promising results, with marked improvements in slowing tumour growth and spread.
Almost twice as many patients responded to osimertinib compared with another chemotherapy treatment, which held off cancer progression by an additional four months.
Mrs Calabia has been able to take the once-daily oral medication for the past four months through an access scheme provided by the drug manufacturer AstraZeneca.
"I didn't know what I was going to do if I didn't have a medication that worked. I was so worried.
"We [my doctor and I] are hoping this will work for me, and keep working," Mrs Calabia said. "I feel better mentally, physically, emotionally. I'm relying on it."
Associate Professor Nick Pavlakis, president of the Australasian Lung Cancer Trials Group and senior staff specialist at Royal North Shore Hospital's department of medical oncology, said the TGA approval was a big step forward for treating cancers with the mutation, which disproportionately affects non-smokers, particularly women of Asian descent.
"Having a drug now to target [the T790M mutation] gives these patients a great deal of hope for longer survival and better quality of life without having to go onto chemotherapy," he said.
"It takes a disease that was an immediate life sentence and turns it into a chronic illness.
"Ultimately [the cancer] will become resistant in the end, but it changes the horizon … these patients can live longer and with better quality of life," he said.
The drug also had a number of advantages over other TKIs, including longer overall remission periods and fewer side effects, said Professor Pavlakis, who receives funding from AstraZeneca as a consultant.
"People often return to the workforce and can stay there," he said.
The TGA tick could potentially make way for the Pharmaceutical Benefits Advisory Committee to approve listing the drug on the PBS, Professor Pavlakis hoped.
Patients currently access the drug via clinical trials and access schemes. US pharmacies sell monthly doses of Tagrisso for roughly $US14,000 ($19,300).
Britain's National Institute of Health and Care Excellence (NICE) recommended in October that osimertinib be made available on the Cancer Drugs Fund, and the FDA approved the drug in September.
The most common reported adverse reactions were diarrhoea, rash, dry skin, paronychia and pruritus.