New York City is Now Epicenter of Coronavirus COVID-19 Outbreak in the USA
Photo by Pixabay on Pexels.com

Pfizer Stock (PFE) on Investor Radar Today, Nov 23, 2018, After FDA Approval of Its Acute Myeloid Leukemia Drug Daurismo (glasdegib)

FDA News Release

FDA approves new treatment for patients with acute myeloid leukemia

For Immediate Release
November 21, 2018

Release

The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today’s approval gives health care providers another tool to use in the treatment of AML patients with various, unique needs. Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy,” 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.

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. The National Cancer Institute at the National Institutes of Health estimates that in 2018, approximately 19,520 people will be diagnosed with AML and approximately 10,670 patients with AML will die of the disease. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy related toxicities.

The efficacy of Daurismo was studied in a randomized clinical trial in which 111 adult patients with newly diagnosed AML were treated with either Daurismo in combination with LDAC or LDAC alone. The trial measured overall survival (OS) from the date of randomization to death from any cause. Results demonstrated a significant improvement in OS in patients treated with Daurismo. The median OS was 8.3 months for patients treated with Daurismo plus LDAC compared with 4.3 months for patients treated with LDAC only.

Common side effects reported by patients receiving Daurismo in clinical trials include low red blood cell count (anemia), tiredness (fatigue), bleeding (hemorrhage), fever with low white blood cell count (febrile neutropenia), muscle pain, nausea, swelling of the arms or legs (edema), low platelet counts (thrombocytopenia), shortness of breath (dyspnea), decreased appetite, distorted taste (dysgeusia), pain or sores in the mouth or throat (mucositis), constipation and rash.

The prescribing information for Daurismo includes a Boxed Warning to advise health care professionals and patients about the risk of embryo-fetal death or severe birth defects. Daurismo should not be used during pregnancy or while breastfeeding. Pregnancy testing should be conducted in females of reproductive age prior to initiation of Daurismo treatment and effective contraception should be used during treatment and for at least 30 days after the last dose. The Boxed Warning also advises male patients of the potential risk of drug exposure through semen and to use condoms with a pregnant partner or a female partner that could become pregnant both during treatment and for at least 30 days after the last dose. Daurismo must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Patients should also be advised not to donate blood or blood products during treatment. Health care providers should also monitor patients for changes in the electrical activity of the heart, called QT prolongation.

The FDA granted this application Priority Review designation. Daurismo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Daurismo to Pfizer.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626443.htm

Check Also

New York Federal Reserve Adds Liquidity to Financial Markets to Quell Volatility!

China Promises to Cut Tariffs on 800 US Products Americans Now Have Jobs and Have …

US Economy Looks to Continue Good Performance into 2020, But 2021 Could Be Another Story

We should expect some degree of decline in 2021 especially if 2020 sees rapid growth, simply because the economy goes through boom and bust cycles. So, 2021 could be the year for the bust phase of the business cycle because 2020 showed us the boom phase of the cycle.

Market Volatility and Global Economic Slow Down Could Cause Widespread Use of Cryptocurrency by Governments

Here comes the irony of the U.S. economy. This irony shows, that increase volatility, is at play. The first proof of this, screams out in the form of the Disappointing ISM Manufacturing PMI for November, which came in at 48.1% missing market forecasts of 49.2% and a previous reading of 48.3%.

The U.S. Economy Improved in October, Housing Starts and Building Permits Data Show

The U.S. economy continues to show signs of improvement. It has been the third week in a row that we have seen positive economic numbers. This week’s offering provides us with positive releases such as the Housing Starts, Building Permits, Existing Home Sales, Manufacturing PMI, Services PMI, and Consumer Sentiment Reports.

Recent Interest Rate Cuts, Already Showing Economic Improvements

When the economy begins to expand, the inflation rate will also begin to increase. Therefore, the Federal Reserve must be extremely careful when cutting interest rates because cutting interest rates too much could cause inflation to rise too quickly.

U.S. Economy Boosted by Improved Trade Deficit and ISM Non-Manufacturing PMI

The Trade Balance, released by the Bureau of Economic Analysis, measures the difference in value between imported and exported goods or services over the reported period. A positive number indicates that more goods and services were exported than imported. A Trade Balance with a negative value is called a trade deficit while a Trade Balance with a positive number is called a trade surplus. As we have mentioned previously a Trade Balance equals the value of exports minus the value of imports.

Recession Worries Caused Fed to Cut Interest Rate By 25 Basis Points to 1.75 Percent

Even consumers don’t feel all that confident about the economy. The recent Conference Board Consumer Confidence Report for October showed that consumers are less confident about the economy now, than they were a month earlier. The CB Consumer Confidence Report released Tuesday, October 29, 2019, at 10 AM, for October, posted current readings of 125.9 missing forecast of 128.0 and a previous reading of 126.3.

Copyright © 2020 · All Rights Reserved · Mstardom Finance, a Subsidiary of Mstardom, Inc.

%d bloggers like this: