FDA updates on Tasigna to indicate that certain patients with a type of leukemia (CML) may be eligible to stop treatment after response is sustained.
This is a first -Discontinuation in treatment for chronic myeloid leukemia and Tasigna.
Tasigna was first approved in 2007 by the FDA for the Treatment of Philadelphia Chromosome positive (PH+) chronic myeloid leukaemia (CML).
In hopes of a better year ahead, I was stunned with today’s update. Patients with chronic CML at the early phase, who have been on Tasigna for over three years with response to treatment as detected by tests, has received mandates to stop administration if Tasigna.
“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“Today’s approval shows that some patients may be able to stop treatment with Tasigna altogether if they are showing a strong response to therapy. While we welcome this progress in patient care, it’s important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence.”
The cancer of the bone marrow which causes the body to reproduce white blood cells in excess is called CML and patients with CML have Philadelphia Chromosomes causing a production of protein called BCR-ABL.
The National Institute of Health where the National Cancer Institute is located, made an estimate that approximately 8,950 patients will be diagnosed with CML this year and 1,080 will eventually die of the disease.
Tasigna is an oral chemotherapy drug administered to patients who have not responded well to Chemotherapy and it is aimed at interfering with cancerous growth and reproduction. It is in relation to CML.
This discontinuation was based on two trials. In both trials, patients were required to meet rigorous criteria to exhibit cancer had responded to treatment before stopping the medication.
It was carried out among 190 patients, newly diagnosed with CML who stopped Tasigna after three or more years of taking it and meeting other specified criteria.
51.6 percent were still in the TFR stage after approximately 48 weeks and 48.9 percent were still in the TFR stage after approximately 96 weeks.
This was done among 126 patients who had made a switch from the cancer drug imatinib and stopped Tasigna three or more years of taking it.
57.9 percent were still in the TFR stage after approximately 48 weeks and 53.2 percent were still in the TFR stage after approximately 96 weeks.
For both trials, there are frequent and regular monitoring of RNA, that is, specific genetic that specifies the BCR-ABL (protein) in the blood with a test at the mandate of FDA.
The tests were critical to safe discontinuation of Tasigna as this tests with high accuracy could detect the the first type of relapse.
Side effects on patients who discontinued the medication included body aches, pains in extremities and other musculoskeletal symptoms.
Mild side effects of taking Tasigna includes rash, headache, nausea and fatigue, cough, diarrhoea, constipation, respiratory inflammation, fever and joint pains, chills and night sweats, anaemia and vomiting.
Severe side heart blockages, pancreas inflammation, electrolytes abnormally, severed damage of the liver, severe hemorrhage, actual surgical removal of the tummy and fluid retention and pregnant/ breastfeeding women can not take the Meds as it may cause harm to the new born baby or fetus.
These are real problems.
The severe horrible side effects of Tasigna medication are less frequent in patients who have discontinued the medication.
The real question is the long term outcomes of discontinuation of Tasigna versus the continuation of Tasigna. (Which is yet to be known).
Tasigna has a labelling on its box warning patients on the risks of sudden death or abnormal heart rhythm.
It also must be avoided by patients with low levels of potassium or magnesium in the blood. Mind you, there have been reports of sudden death and patients taking this medication should not eat two hours prior to or an hour after taking Tasigna as stated on its box package.
There is a priority review to undergo by patients after six months of discontinuation. Tasigna received Orphan Drug designation, with incentives to assist and encourage the development of drugs for rare diseases.
The FDA has granted the approval of the Tasigna label changes to Novartis Pharmaceuticals Corporation.
The Lord help and keep us all. While we remain mindful of the food we eat to help our skin outwardly and bodies internally, if it could help prevent these ailments, let’s keep at it to the maximum.
What do you think?