Opdivo (nivolumab)
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of metastatic squamous non-small cell lung cancer, Approved March 2015
WEDNESDAY, March 4, 2015 (HealthDay News) -- U.S. Food and Drug Administration approval of Opdivo (nivolumab) has been expanded to include advanced non-small cell lung cancer (NSCLC), the agency said Wednesday in a news release.
Lung cancer is the leading cause of cancer death in the United States, having been diagnosed more than 224,000 times and causing more than 159,000 deaths in 2014, the FDA said. NSCLC is the most common type, affecting seven of eight people with lung cancer.
Opdivo inhibits a protein that prevents the immune system from attacking cancer cells, the agency said. The drug is sanctioned for people who have been treated with platinum-based chemotherapy.
Opdivo was clinically compared to another anti-cancer drug, docetaxel, in a study involving more than 270 people with NSCLC. People who received Opdivo lived an average of 3.2 months longer than people given docetaxel, the FDA said.
The most common side effects of Opdivo are fatigue, shortness of breath, muscle and bone pain, loss of appetite, cough, nausea and constipation. More severe adverse effects included immune reactions involving healthy organs, including the lungs, colon, liver, kidneys and hormone-producing glands.
Opdivo was approved previously to treat advanced melanoma among people who don 't respond to other medicines. ( 'FDA Expands Approved
So, with this increase in toxicity over single agent inhibition of the PD-1 checkpoint, an increase in efficacy would be required to support development of the combination. At the doses of tremelimumab considered tolerable, among PD-L1 positive patients (based on staining in 25% of the cancer cells), the response rate does not appear superior to single agent PD-1 inhibition.2,4 However, among those without high level PD-L1 expression, 4 of 14 patients responded to the combination, while with approved agents, no more than 2 patients would anticipated to respond.2,4
2. Denosumab has been FDA approved for 2 indications rather than 1 which is true for most of its competition. Both the conditions are prevalent in the population and their incidence is growing. This will allow the drug to tap unmet needs for the available market.
In the past years, there has been a major paradigm shift in the management of non-small cell lung cancer also known as (NSCLC). NSCLC should now be further sub-classified by histology and driver mutation if one is known or present. Translational research results now allow such mutations to be inhibited by either receptor monoclonal antibodies (mAb) or small molecule tyrosine kinase inhibitors (TKI). Whilst empirical chemotherapy with a platinum-doublet remains the gold standard for advanced NSCLC without a known driver mutation, targeted therapy is pushing the boundary to significantly improve patient outcomes and quality of life. In this review, we will examine the major subtypes
The trial involves giving a combination therapy to patients with advanced squamous cell carcinoma. Patients with advance malignancies may have other comorbidities and may be receiving multiple medications. This will increase the risk of side effects and the possibility of drugs interactions when receiving the investigational product. The investigational product itself has a wide range
neoadjuvant chemotherapy, the tumors are very aggressive and associated with a poor prognosis as well as a
If you or your loved one has a cancer diagnosis, you want to find the best treatment possible. Understandably, this can be overwhelming. The good news is treatments and technologies advance quickly. When researching treatment options, you'll want the most accurate and recent knowledge. To help, we've compiled information about the latest cancer treatments in greater Baltimore so you can make informed decisions and find the expert care you and your family deserve.
VET is a term that first appeared in the National Vocational Education and Training Regulator Act 2011 and refers to a group of frameworks and systems that define the operational set up of RTOs.
Golimumab is a fully human mAb approved by US and EU in 2009. It gives significant treating
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II. Main Point: The most recent approach for a new treatment was approved by the F.D.A. this year.
Unlike Gilead that has only one product in its Oncology line, Bristol-Myers Squibb presently have four different drugs namely: Erbitux –an epidermal growth factor receptor (EGFR) antagonist for the treatment of Head & Neck cancer and Colorectal cancer,(2) Opdivo (nivolumab) for the treatment of unresectable or metastic melanoma and lungs cancer, (3) Syrcel( dasatinb) for the treatment of newly diagnosed adult with Philadelphia chromosome –positive (ph+) chronic myeloid leukemia and (4) Yervoy (ipilimumob) for the treatment of melanoma a type of skin cancer that spread and as such cannot be remove by surgery. Like Seattle Genetics, the company products use either Antibody-drug Conjugate (ADC) though in a different version by linking potent cytotoxic to monoclonal antibodies targeted to specific tumor cells or immune-oncology, an innovative technology that unlocks the body own immune system to fight against cancerous cells. It also expanded its focus to Nolch inhibitor (used in blocking powerful pathway that promotes tumor cell survival for certain other types of cancer. (Bristol-Myer Squibb, 2014) Because the technology is similar but used differently, BMS would be considered a close competitor who currently has the advantage of having four targeted specific drugs and 12 other oncology and immune-oncology in various trial phases.
The most common cause of lung cancer is smoking cigarettes. 80% of people who have lung cancer got it from smoking. The longer you smoke cigarettes the better chance of getting lung cancer. Smoking at a young age increases the chance of getting lung cancer more then starting to smoke as an adult. The sooner you quit, the better your life will be. Passive smoking (secondhand smoking) can give you lung cancer if exposed for a long time to it.
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Former Senators Bob Dole and Tom Daschle is in favor for cleaner fuels and renewable resources Patrick Mazza, (n.d.).