FDA Panel Approves Imatinib for Pediatric ALL....

The US Food and Drug Administration (FDA) today approved imatinib (Gleevec, Novartis) for the treatment of newly diagnosed pediatric acute lymphoblastic leukemia (ALL) that is Philadelphia chromosome (Ph) positive.
"We are pleased that the number of cancer medications for children is on the rise," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research, in a press statement.
In 2011, imatinib was approved to treat children newly diagnosed with Ph-positive chronic myeloid leukemia (CML).
However, ALL is the most common type of pediatric cancer, affecting approximately 2900 children annually, according to the FDA.
The safety and effectiveness of imatinib for pediatric patients with Ph-positive ALL were established in a clinical trial that enrolled children (1 year and older) and young adults with very-high-risk ALL (>45% chance of experiencing complications from their disease within 5 years of treatment).
The 92 patients with Ph-positive ALL enrolled in the trial were divided into 5 treatment groups, with each successive group receiving imatinib plus chemotherapy for a longer period.
Fifty of the Ph-positive ALL patients received imatinib for the longest period, and 70% of these patients did not experience relapse or death within 4 years. In addition, patient deaths decreased with the increasing duration of imatinib treatment in combination with chemotherapy, according to the FDA.
The most common adverse effects observed in children with Ph-positive ALL treated with imatinib plus chemotherapy were decreased neutrophil levels, decreased blood platelets levels, liver toxicity, and infection.
Imatinib is a tyrosine kinase inhibitor that blocks cancer-promoting proteins, and should be used in combination with chemotherapy to treat pediatric Ph-positive ALL.

Imatinib has been a practice-changing drug in this setting, according to the Children's Oncology Group, which conducted the pivotal clinical trial.
According to the group's Web site, the preferred treatment for Ph-positive ALL before imatinib was stem cell transplantation followed by 3 to 6 months of chemotherapy. However, cure rates were less than 50% with this approach. Imatinib in combination with chemotherapy has doubled cure rates, and stem cell transplantation is no longer automatically considered to be the best way to treat children with Ph-positive ALL.
Imatinib was granted accelerated approval in 2001 by the FDA to treat patients with blast-crisis, accelerated-phase, or chronic-phase Ph-positive CML who have failed interferon-alpha therapy. The drug was also approved in 2012 for the treatment of adults whose Kit (CD117)-positive gastrointestinal stromal tumors (GIST) had been surgically removed.

Personal growth and insperation!

Today’s side though!

                I’m sitting here pondering all that I have experienced over the year in both my personal and career life. I have considered all that has occurred and is occurring and concluded that although I have experienced many trials and tribulations. Nothing has prepared me for this phase of my life. As a med student I am constantly researching, memorizing various elements of the human body and the conditions in which the human body is affected. I spend countless hours studying facts, theory’s, treatments. And have now resorted to sleeping with my medical books, laptop, ipad, and cell phone.  I have sacrificed my sleep, social life, and personal time, all in the name of medicine. I guess the question remains, why do physicians, nurses, bio tech, radiologist, and more sacrifice themselves, pushing them self to the breaking point in order to heal anther? What is it that drives a person into the medical field?

                I suppose each of us has our own reasoning as to why we choose to live and thrive within the medical field. I for one started my journey with wanting nothing more than to understand the condition that threatens a human body. I was and am fascinated by the human body. It is the most perfect machine ever built. And just like other machines, the human body had its defects as well. My thirst, drive, and need to understand the human body had absolutely nothing to do with the individual. It was about the condition that affects the body. However, and with two years remaining. My opinion has since changed. I can pin point the exact moment in time when my ill sought opinion had shifted. Although, I have had several patients that where terminally ill, my opinion did not change until I had my first oncology/palliative care patient.

 I was assigned to a patient whom was suffering from MBC/Lymphoma and was roughly 10 years younger than I. That evening after being assigned to her, I entered her room with that “standard” meet and great, make the patient feel important, mentality. An hour and a half had passed and I had quietly left her room, exited the building, and headed straight to my vehicle park off in the distant parking lot. After leaving the parking lot, I found myself crying the entire way home.  Until this day, I cannot tell you exactly what it was about her and or what occurred during our first encounter that had moved me so much. But over the course of week(s) and right up to the time of her passing (six weeks totaling), I can honestly say that I have learned more about the human spirit than any text book, lecture, professor, attending, and or anyone for that matter, from this single patient. She was my eye opener.

Today, when asked why the medical field and why oncology. My answer is always the same. I am blessed to be the student of what the true meaning of the human spirit and its will to survive. Those that I come into contact with (patients) have such a profound wisdom regarding life and the meaning of life that it is something to marvel and envy. Regardless of their age, I have found all of my patients to have same in-depth wisdom. I am not sure why or how one finds such wisdom.  Perhaps this insight stems from the very real reality of their destiny. Unlike the mainstream population, the individuals (patients) I am in contact with. Do not have the rose color glasses. They see themselves and the world in which they reside in as is rather then what will be. I would like to believe that it is because many of them have already found their peace spiritually, mentally, and physically (if there is such a thing).