On November 1st 2013, the U.S. Food and Drug Administration (FDA) granted approval to obinutuzumab (previously known as GA101), a CD20-directed cytolytic antibody for use in combination with chlorambucil for treating patients with previously untreated chronic lymphocytic leukemia (CLL) (1). Obinutuzumab is unique because it is the first drug approved with the FDA’s Breakthrough Therapy designation, since the agency began using that designation in 2012 as per the requirements in the Food and Drug Administration Safety and Innovation Act (FDA SIA). Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world with an annual incidence of 4.2/100 000 population (2). The incidence increases to >30/100 000/year at an age of more than 80 years. The median age at diagnosis is 72 years. About 10% of CLL patients are reported to be younger than 55 years of age.
Breakthrough Therapy designation aims to expedite the development of drugs for serious or life-threatening conditions. The criteria for this designation require preliminary clinical evidence that demonstrates the new drug having substantial improvement on one or more clinically significant endpoints over available therapy. Determination of whether the advantage over existing therapy is substantial is a matter of judgment and depends upon both the magnitude of the therapeutic effect, including its duration and the clinical importance of the observed outcomes. In general, the preliminary clinical evidence should show a definite advantage over the available therapy. What differentiates the breakthrough therapy designation from other FDA approaches to expedited drug development including fast track designation, priority review and accelerated approval —all of wh...
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...ons to minimize the risk of infusion related hypersensitivity reactions. These premedications include a glucocorticoid, acetaminophen and an anti-histamine.
The drug is approved with a boxed warnings about Hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML), either of which may be fatal. HBV reactivation can possibly result in fulminant hepatitis, hepatic failure, and death. It is recommended to screen all patients for HBV infection before initiating treatment and to monitor HBV positive patients during and after treatment with this drug. PML is suspected in any patient presenting with new onset or changes to prior neurologic manifestations. Development of PML in obinutuzunab treated patients warrants discontinuation of this drug as well as stoppage/ dose reduction of any concomitant chemotherapy or immunosuppressive therapy.
...se them to become resistant to Gleevec. These mutations change the shape of bcr-abl to some extent that the treatment will not work on them, such that Gleevec can no longer bind to bcr-abl and activate it; which leads to gleevec resistance within patients with CML. Yet, using another Kinase inhibitor as an alternative to Gleevec which would block the mutated version of bcr-abl that causes resistance with Gleevec could be used to treat the new mutated version of bcr-abl. Such as: dasatinib, nilotinib, bosutinib, or ponatinib. Subsequently, even if the bcr-abl gene is not found in the patients blood, that still doesn't guarantee they are cured for now, so they are recommended to stay on the drug indefinitely. If all fails then patients are told to consider stem cell transplant as a last resort, especially for younger people who have a donor with a matching tissue type.
Overall, I retain three goals for this clinical day: Safely and efficently administer medication, enhance my nursing/CNA skills, and determine how to implement infection control into a health care setting. This week reflects my assigned time to administer medication in a health care setting for the first time, with a resident who retains nearly twenty medications. I except this experience will be a great learning experience, but it will also subsist slightly stressful. With the assistance of my FOR, my goal is to administer all of my resident 's medications without complications. To ensure that medication safety, I will perform the six medication rights and three checks prior to administration. Along with medication administration, a goal
The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products.
...0’s cancer mortality rates have dramatically decreased from 10% to over 80% for leukemia. Overall decline in mortality for cancer was nearly 54% from 1978 to 2008 (National Cancer Institute, 2011). Decrease in mortality rates are due to improvements in cancer treatments. Recent advances in treatments are due to aggressive cancer therapies and collaboration of findings from clinical trials. More than 80 percent of patients are expected to be long term cancer survivors (National Cancer Institute, 2011).
strict or they can take too long to approve a drug. But I think for the most part, the FDA is really
With new age purpose and research for the last 60 plus years, LLS has invested over $875 million dollars to advance cancer treatments. LLS invests time in blood cancer research with various programs. Two major programs are Specialized Center of Research (SCOR) and Transitional Acceleration Program (TAP). SCOR's research is surrounded around innovative blood research in the discovery to find the new drugs and treatments. While “through TAP, LLS forges partnerships with universities and biotechnology companies, bringing resources that can more rapidly transform promising research into critically needed therapies, including therapies that might otherwise go undeveloped.”
...ed with this drug. One of the major concerns for this treatment is the development of kidney problems, but are usually reversible after treatment is ceased. “Approximately 90-95% of adults with Hepatitis B recover and remain immune to re-infection throughout their lifetime,”(Everson and Weinburg, 2002, pg.142-143)
When I began my research, I figured, what better way to start digging in than to hear what a professional has to say. So I contacted Dr. Diana Port, Pharm.D., a Pharmacist in Meadowlands Hospital in Secaucus, New Jersey. I asked her to tell me the first thing that came to her mind when I told her the following two words: ‘Creativity’ and ‘Medicine’. Barely finishing my sentence, she answered me with one, Gleevec. She explained to me that in 2001, the FDA approved of a cancer-fighting drug, which would later be called Gleevec for the treatment of Chronic Myelogenous Leukemia (CML). When the drug first came out, people were literally calling it names like “The Silver Bullet” or “The Miracle Drug” because of how amazing it was (Pray).
For a drug to get to market it must go through several stages of research and development (Abbott and Vernon). Starting with discovery research, preclinical testing on animals, three phases of clinical trials on humans, and finally FDA (Food and Drug Administration) approval (Abbott and Vernon). Out of several thousands of drugs only a few will make it to the FDA approval stage (Abbott and Vernon). Testing is a highly regulated, time consuming, and expensive process. From beginning to end the process can take fifteen years and less than one of five compounds will make it to market where it is still not guaranteed to succeed (Abbott and
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
However, the only remedy to counter this fatal condition from getting bad to worse is the immediate administration of Adrenaline. Adrenaline (Epinephrine) is administered through an autoinjector. Use of an autoinjector ensures safe and easy administration of the medicine.... ... middle of paper ... ...(2011).
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
They were often administered at night when his room would be dark and he could not see the bag of packed red blood cells hanging from his intravenous (IV) infusion pump pole. He was receiving narcotic pain medicine resulting in very mild sedation and causing him to sleep more. Jose was also persistently febrile and overall did not feel well so his wakefulness and alertness were decreased. If he questioned what was hanging from his IV pole or why his vital signs needed to be checked again, he was told it was a different type of IV fluid or a different type of medication he needed to
Keep the patient NPO, and establish two IV access sites with a large bore catheters running one IV with NS at KVO and morphine sulfate for pain. Initial laboratory testing including a complete blood cell count (CBC), basic metabolic panel (BMP), cardiac enzymes (creatine kinase, creatine kinase-MB, and cardiac Troponin) and repeat in 90 min. Administer antiplatelet ASA 324mg PO (Sen, B., McNab, A., & Burdess, C., 2009, p. 18). Before administering nitroglycerin 0.4 mg SL (every 5 minutes up to three doses) reassess blood pressure if systolic <90 mmHg, patient has used cocaine in the last 24 hours, or taking PDE-5 inhibitors do not administer. Thrombolytic therapy should be implemented within 30 minutes from the patient’s arrival to the emergency department, and if they are a candidate for cardiac catheterization it should be done within 90 minutes from the patient being admitted to the hospital. Delay on either therapy option increases the risk of mortality (Kosowsky, Yiadom, Hermann, & Jagoda, 2009, p. 10).
of treatment that has not been tried yet or treatment that may come in the