lunes, 30 de noviembre de 2015

Approved Drugs > Elotuzumab

Approved Drugs > Elotuzumab



Elotuzumab



On November 30, 2015, the U. S. Food and Drug Administration approved elotuzumab (EMPLICITI, Bristol-Myers Squibb Company) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.
 
Elotuzumab is a monoclonal antibody directed against Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7). SLAMF7 is present on myeloma cells and is also present on natural killer cells. 
 
The approval was based on a multicenter, randomized, open-label, controlled trial evaluating progression-free survival (PFS) and overall response rate (ORR) in patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy.  A total of 646 patients were randomized (1:1) to receive elotuzumab in combination with lenalidomide and dexamethasone (n=321) or lenalidomide plus dexamethasone alone (n=325).  Patients continued treatment until disease progression or the development of unacceptable toxicity.
 
The trial demonstrated a statistically significant improvement in both PFS and ORR, the trial’s co-primary endpoints.  The median PFS in the elotuzumab-containing arm was 19.4 months and 14.9 months in the lenalidomide plus dexamethasone alone arm (hazard ratio 0.70, 95% CI: 0.57, 0.85; p = 0.0004).  The ORR in the elotuzumab-containing arm was 78.5% (95% CI: 73.6, 82.9) compared to 65.5% (95% CI: 60.1, 70.7) in the lenalidomide plus dexamethasone alone arm (p=0.0002). 
 
The safety data reflect exposure in 318 patients to elotuzumab in combination with lenalidomide and dexamethasone and 317 patients to lenalidomide plus dexamethasone. The most common adverse reactions (greater than or equal to 20%), with an increased rate in the elotuzumab arm compared to the control arm, were fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia. 
 
Other important adverse reactions include infusion reactions, infections, second primary malignancies, hepatotoxicity, and interference with determination of complete response.  As elotuzumab is an IgG kappa monoclonal antibody, it can be detected in the serum protein electrophoresis and immunofixation assays used to assess response. 
 
Serious adverse events occurred in 65.4% of patients in the elotuzumab-containing arm compared to 56.5% in the lenalidomide plus dexamethasone alone arm. The most common serious adverse reactions were pneumonia, pyrexia, respiratory tract infection, anemia, pulmonary embolism, and acute renal failure. 
 
The recommended dose and schedule for elotuzumab is 10 mg/kg intravenously every week for the first two cycles and every 2 weeks, thereafter, until disease progression or unacceptable toxicity with lenalidomide 25 mg daily orally on days 1 through 21.  Dexamethasone is administered as follows: In weeks with elotuzumab infusion, dexamethasone is to be administered in divided doses, 8 mg intravenously prior to infusion and 28 mg orally; in weeks without elotuzumab infusion, dexamethasone is to be administered 40 mg orally.  Pre-medication with an H1 blocker, H2 blocker, and acetaminophen should be administered prior to elotuzumab infusion.
 
Elotuzumab is being approved prior to the Prescription Drug User Fee Act (PDUFA) goal date of February 29, 2016.  This application was granted priority review and had breakthrough therapy designation.  A description of these expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at:http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
 
 
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

FDA Basics Webinar- Dec 1: Role of FDA in HIV Diagnosis

The United States Food and Drug Administration (FDA) regulates the tests that detect infection with Human Immunodeficiency Virus (HIV), the virus that causes AIDS (acquired immune deficiency syndrome).
Join the webinar to learn how FDA regulates HIV diagnostic, monitoring, and blood donor screening tests.
Date: Tuesday, Dec 1, 2015
Time: 1p.m. EST
Speaker: Pradip N. Akolkar, PhD from the Center for Biologics Evaluation and Research (CBER)
To join the webinar, visithttps://collaboration.fda.gov/fdacber_basics/

New Funding Opportunity Announcements

New Funding Opportunity Announcements

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New Funding Opportunities 

All funding opportunities can be found here.

Webinar: Women and Caregiving

Webinar: Women and Caregiving

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Women & Caregiving

Wednesday, December 2, 2015 
| 1:00 p.m. to 2:00 p.m. ETRegister here!
Family caregivers are a growing population, largely
composed of women. Not only is it important to
understand the needs of these women, it is also
beneficial to understand the competing demands
on their lives. This webinar will provide public health
professionals with better understanding of the complex
needs of caregivers and how best to communicate
with them. Presenters include:
  • Jennifer Wolf, Johns Hopkins University
  • Judith Vick, Johns Hopkins University
  • Cheryl Clark, Philadelphia Corporation for Aging

FDA Approves T-VEC to Treat Metastatic Melanoma - National Cancer Institute

FDA Approves T-VEC to Treat Metastatic Melanoma - National Cancer Institute



National Cancer Institute

11/25/2015


On October 27, the U.S. Food and Drug Administration (FDA) approved the first oncolytic virus therapytalimogene laherparepvec (T-VEC, or Imlygic®).The agency approved T-VEC for the treatment of some patients with metastatic melanoma that cannot be surgically removed.

The approval was based on the results of a multicenter phase III clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes. 

FDA Approves Talimogene Laherparepvec to Treat Metastatic Melanoma

November 25, 2015 by NCI Staff
Melanoma cells dividing
T-VEC, an oncolytic virus, works by infecting and killing tumor cells, like these dividing melanoma cells, and stimulating an immune response against cancer cells throughout the body.
Credit: Wellcome Images, CC BY-NC-ND 4.0
On October 27, the U.S. Food and Drug Administration (FDA) approved the first oncolytic virus therapytalimogene laherparepvec (T-VEC, or Imlygic®).The agency approved T-VEC for the treatment of some patients with metastatic melanoma that cannot be surgically removed.
The approval was based on the results of a multicenter phase III clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes. 
Substantially more patients in the trial treated with T-VEC had a decrease in the size of their skin and lymph node lesions that lasted at least 6 months compared with patients treated withgranulocyte macrophage colony-stimulating factor.
Read more about the trial results on which the FDA based its approval.

Donating Your Tissue for Research

National Cancer Institute





11/27/2015 12:12 PM EST
Short video that discusses tissue donation as part of cancer research. Sue Scott, cancer survivor, and her physician-researcher, Christian Hinrichs, MD, of the National Cancer Institute describe what tissue donation has meant to them and why they are such passionate advocates for donating tissue from clinical procedures for cancer research. Pathologist and cancer survivor, Hala Makhlouf, MD, PhD also shares her insights on tissue donation for research as part of her personal cancer journey. For more information, viewers can call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER or visit online at cancer.govor to view a brochure about tissue donation in research, visit: http://www.cancer.gov/tissue-donation.

8th Annual Sentinel Initiative Public Workshop

8th Annual Sentinel Initiative Public Workshop
FDA Logo
Wednesday, February 3, 2016 from 9:00 AM to 4:00 PM (EST)

Renaissance Washington, DC Dupont Circle Hotel | 1143 New Hampshire Avenue Northwest | Washington, DC 20037
The Food and Drug Administration (FDA) will hold the Eighth Annual Sentinel Initiative Public Workshop on Wednesday, February 3, 2016. Convened by the Center for Health Policy at the Brookings Institution and supported by a cooperative agreement with FDA, the workshop will bring stakeholders together to discuss a range of topics in active medical product surveillance. Workshop presentations will include an update on the state of FDA’s Sentinel Initiative, overview of the transition from the Mini-Sentinel pilot to the full Sentinel System, and description of key activities and uses of the Sentinel System in 2015. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its capabilities. The workshop will also engage stakeholders to discuss current and emerging Sentinel projects.
Please note the registration is required for the workshop.  In order to register, visit following event website:http://www.eventbrite.com/e/8th-annual-sentinel-initiative-public-workshop-registration-19294863456.

Centers for Disease Control and Prevention (CDC) Health Matters for Women[TM] E-Newsletter Update

Centers for Disease Control and Prevention (CDC) Health Matters for Women[TM] E-Newsletter Update

Health Matters for Women newsletter from the CDC - US Department of Health and Human Services - Centers for Disease Control and Prevention

Health Matters for Women



Federal Agency News

National, State and Local News

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CDC Podcasts
Listen to the latest podcasts on women’s health.
CDC E-Cards
Send women’s health e-cards.

Centers for Disease Control and Prevention (CDC) Health Matters for Women[TM] E-Newsletter Update

Centers for Disease Control and Prevention (CDC) Health Matters for Women[TM] E-Newsletter Update

Health Matters for Women newsletter from the CDC - US Department of Health and Human Services - Centers for Disease Control and Prevention

Health Matters for Women






New from CDC

AnnouncementYvonne Green, RN, CNM, MSN, Director of CDC’s Office of Women’s Health, retires on Monday, November 30.
Gestational Weight Gain — United States, 2012 and 2013
The overall prevalence of appropriate gestational weight gain (GWG) was 32.1%, whereas the prevalence of inadequate GWG was 20.4% and the prevalence of excessive GWG was 47.5%.
Current Cigarette Smoking Among Adults — United States, 2005–2014
In 2014, prevalence was higher among males (18.8%) than females (14.8%), and was highest among adults aged 25–44 years (20.0%) and lowest among persons aged ≥65 years (8.5%).
Increase in Incidence of Congenital Syphilis — United States, 2012–2014
After four years of decline, congenital syphilis rates increased by 38% from 2012-2014. Of 458 congenital syphilis cases in 2014, 22% of mothers received no prenatal care.
Diabetes and Pregnancy: Erin’s Story
If you are a woman with diabetes, you still can have a healthy baby. Read Erin’s story and learn how to get ready for a healthy pregnancy.
Health Insurance Marketplace and Women
The Marketplace is the way millions of uninsured Americans are getting affordable, high-quality insurance coverage. Sign up by January 31, 2016 and learn about preventive services available to women at no cost.
CDC’s VetoViolence Website
VetoViolence is CDC's online source of free violence prevention trainings, tools, and resources. Check out the VetoViolence website to learn how to stop violence, before it happens.
Prevalence of Obesity Among Adults and Youth: United States, 2011–2014
Overall, the prevalence of obesity among women (38.3%) was higher than among men (34.3%). For adults aged 20–39 and 40–59, the prevalence of obesity was higher among women than among men, but the difference between older women and men aged 60 and over was not significant.
Gather and Share Your Family Health History
The holiday season offers many opportunities for your family to share a meal—and your family health history. If you are concerned about a disease running in your family, collect your family health history and talk to your doctor at your next visit.
Current Contraceptive Use Among Women Aged 15–44 in the United States, 2011–2013
Among women currently using contraception, the most commonly used methods were the pill (25.9%, or 9.7 million women), female sterilization (25.1%, or 9.4 million women), the male condom (15.3%, or 5.8 million women), and long-acting reversible contraception (LARC)—intrauterine devices or contraceptive implants (11.6%, or 4.4 million women).
Pregnant? Be Careful with Soft Cheeses
Learn about CDC resources, including a fotonovelainfographic, and fact sheet, that remind pregnant women of the dangers of Listeria.
CDC Responds to Broad Challenges Facing US Cancer Survivors
The number of cancer survivors — people who live after a cancer diagnosis — is expected to grow substantially over the next few decades as the U.S. population ages and as early detection methods and treatments continue to improve.
Public Health Strategies to Prevent Preterm Birth
This session of Grand Rounds discusses how combined efforts to improve surveillance data, better medical care and prevention, and stronger public health partnerships can accelerate progress in reducing preterm births and improving neonatal outcomes.
Hypertension Prevalence and Control Among Adults: United States, 2011–2014
In women, the prevalence of hypertension was higher among non-Hispanic black adults than among all other race and Hispanic origin groups. Prevalence of hypertension was higher among non-Hispanic white (26.5%) than non-Hispanic Asian (23.5%) women.
Abortion Surveillance — United States, 2012
For 2012, a total of 699,202 abortions were reported to CDC. Of these abortions, 688,149 (98.4%) were from 47 reporting areas that submitted data every year during 2003–2012, thus providing the information necessary for evaluating trends.
Lower Levels of Antiretroviral Therapy Enrollment Among Men with HIV Compared with Women — 12 Countries, 2002–2013
This analysis of 765,087 adult ART patient records from 12 countries is the most up-to-date and comprehensive assessment of disproportionate ART enrollment among adult women with HIV compared with men, in resource-limited settings.
Pregnant? Get a Flu Shot!
If you're pregnant, a flu shot is your best protection against serious flu illness. A flu shot can protect pregnant women, their unborn babies, and even the baby after birth.
Premature Birth
Learn more about premature birth, risk factors, and what you can do.
Sexually Transmitted Disease Surveillance 2014
This document presents statistics and trends for sexually transmitted diseases (STDs) in the United States through 2014. This annual publication is intended as a reference document for policy makers, program managers, health planners, researchers, and others who are concerned with the public health implications of these diseases.
HIV Surveillance by Race/Ethnicity through 2014 (slide set)
The 29 slides include information on diagnoses with HIV infection, by sex, race/ethnicity, transmission category, place of birth, and more.
Epidemiology of HIV Infection through 2014
The 35 slides provide information on diagnoses with HIV infection, by sex, transmission category, race/ethnicity, living with diagnosed HIV infection, and more.         
A Daily Pill Can Prevent HIV
This Dear Colleague letter highlights PrEP (Preexposure Prophylaxis) as an essential component in accelerating progress in HIV prevention. PrEP is a powerful prevention tool with the potential to benefit Americans who are most at risk for acquiring HIV.
Daily Pill Can Prevent HIV: Reaching People Who Could Benefit from PrEP – Vital Signs
When taken every day, PrEP is safe and highly effective in preventing HIV infection. PrEP is even more effective if it is combined with other ways to prevent new HIV infections like condom use, drug abuse treatment, and treatment for people living with HIV to reduce the chance of passing the virus to others.
Variation in Residential Care Community Resident Characteristics, by Size of Community: United States, 2014
Overall, 70% of residents in residential care communities were female. The percentage of females was slightly higher in communities with 26–50 beds (72%) than in communities with 4–25 beds (69%) or more than 50 beds (70%).

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