martes, 23 de mayo de 2017

Press Announcements > FDA approves first cancer treatment for any solid tumor with a specific genetic feature

Press Announcements > FDA approves first cancer treatment for any solid tumor with a specific genetic feature



u s food and drug administration

The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.
“This is an important first for the cancer community,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”
MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other places. Approximately 5 percent of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.
Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells. The FDA previously approved Keytruda for the treatment of certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.
Keytruda was approved for this new indication using the Accelerated Approvalpathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe anticipated clinical benefits of Keytruda, and the sponsor is currently conducting these studies in additional patients with MSI-H or dMMR tumors.
The safety and efficacy of Keytruda for this indication were studied in patients with MSI-H or dMMR solid tumors enrolled in one of five uncontrolled, single-arm clinical trials. In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumor samples after treatment began. A total of 15 cancer types were identified among 149 patients enrolled across these five clinical trials. The most common cancers were colorectal, endometrial and other gastrointestinal cancers. The review of Keytruda for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received Keytruda in the trials, 39.6 percent had a complete or partial response. For 78 percent of those patients, the response lasted for six months or more.
Common side effects of Keytruda include fatigue, itchy skin (pruritus), diarrhea, decreased appetite, rash, fever (pyrexia), cough, difficulty breathing (dyspnea), musculoskeletal pain, constipation and nausea. Keytruda can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis). Complications or death related to allogeneic hematopoietic stem cell transplantation after using Keytruda has occurred.
Patients who experience severe or life-threatening infusion-related reactions should stop taking Keytruda. Women who are pregnant or breastfeeding should not take Keytruda because it may cause harm to a developing fetus or newborn baby. The safety and effectiveness of Keytruda in pediatric patients with MSI-H central nervous system cancers have not been established.
The FDA granted this application Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
The FDA granted accelerated approval of Keytruda to Merck & Co.
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.

Clinical Trials Update from NCI, May 23, 2017

Clinical Trials Update from NCI, May 23, 2017

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May Facebook Live thumbnail Facebook Live Event on Advanced Melanoma


On May 25, 2017 at 12:00 p.m. ET, NCI will host a Facebook Live event about Advanced Melanoma Research and Treatment. Subject matter experts from NCI and the University of Chicago will discuss research and treatment for advanced stage melanoma with advocate Jamie Troil-Goldfarb, a clinical trial participant and stage IV melanoma survivor.
 
Collection of Patient-Reported Outcomes Feasible in Cancer Clinical Trials

A new study conducted in collaboration with a cooperative group chemoradiotherapy clinical trial finds that most patients participating in the multicenter trial were willing and able to self report symptomatic adverse events using NCI’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
 
Find a Clinical Trial thumbnail Find NCI-Supported Clinical Trials



Use our search form to find a clinical trial or other research study that may be right for you or a loved one.
 
Clinical Trials Information for Patients and Caregivers
 
What Are Clinical Trials?


Basic information that explains what clinical trials are and why they are critical to making progress against cancer.
 
Use of Placebos


Placebos are rarely used in cancer clinical trials. Learn about the limited role that placebos may play in some clinical trials for cancer.
 
 
NCI-Supported Clinical Trials that Are Recruiting Patients 
 
Ropidoxuridine and Whole Brain Radiation Therapy for Patients with Brain Metastases


This phase I trial studies the side effects and best dose of ropidoxuridine when given together with whole brain radiation therapy to treat patients with cancer that has spread to the brain.
 
Vaccine Therapy and Immunotherapy for Men with Prostate Cancer


This phase I trial studies the side effects of a therapeutic vaccine combined with nivolumab with or without ipilimumab in treating men with prostate cancer.
 
Tocilizumab with or without Antiviral Therapy for Patients with KSHV-Associated Multicentric Castleman Disease


This pilot phase II trial studies tocilizumab in treating patients with Kaposi sarcoma herpes virus (KSHV)-associated multicentric Castleman disease, a type of lymphoproliferative disease similar to lymphoma.

New Images from NCI Visuals Online

New Images from NCI Visuals Online

National Cancer Institute

05/23/2017
Dr. Roscoe Roy Spencer was National Cancer Institute (NCI) Director August 1943 to July 1947. The NCI, established under the National Cancer Institute Act of 1937, is the federal government's principal agency for cancer research and training.
05/15/2017
Drawing shows areas where hypopharyngeal cancer may form or spread, including the bone under the tongue (hyoid bone), cartilage around the thyroid and trachea, the thyroid, the trachea, and the esophagus. Also shown are the upper part of the spinal column, the carotid artery, lymph nodes in the neck, and lining of the chest cavity. An inset shows a cross section of the hypopharynx, larynx, esophagus, and trachea.
05/15/2017
La imagen muestra las áreas donde es posible que el cáncer de hipofaringe se forme o se disemine, incluso el hueso debajo de la lengua (hioides), el cartílago que rodea la tiroides y la tráquea, la tiroides, la tráquea y el esófago. También se muestran la parte superior de la columna espinal, la arteria carótida, los ganglios linfáticos del cuello y el revestimiento de la cavidad torácica. El recuadro muestra un corte transversal de la hipofaringe, la laringe, el esófago y la tráquea.
05/15/2017
Stage IVA anaplastic thyroid cancer; drawing shows cancer in the thyroid gland. The lymph nodes are also shown.
05/15/2017
Cáncer de tiroides anaplásico en estadio IVA; el dibujo muestra cáncer en la glándula tiroides. También se muestran los ganglios linfáticos.
05/15/2017
Stage IVB anaplastic thyroid cancer; drawing shows cancer that has spread to tissue just outside the thyroid gland. The lymph nodes are also shown.
05/15/2017
Cáncer de tiroides anaplásico en estadio IVB; el dibujo muestra cáncer que se diseminó al tejido ubicado justo fuera de la glándula tiroides. También se muestran los ganglios linfáticos.
05/15/2017
Stage IVC anaplastic thyroid cancer; drawing shows other parts of the body where thyroid cancer may spread, including the lymph nodes, lung, and bone. An inset shows cancer cells spreading from the thyroid, through the blood and lymph system, to another part of the body where metastatic cancer has formed.
05/15/2017
Cáncer de tiroides anaplásico en estadio IVC; el dibujo muestra otras partes del cuerpo donde es posible que el cáncer de tiroides se disemine, entre ellas, los ganglios linfáticos, el pulmón y el hueso. El recuadro muestra las células cancerosas que se están diseminando desde la tiroides, a través del sistema sanguíneo y linfático, hasta otra parte del cuerpo en donde el cáncer metastásico se formó.
05/15/2017
Stage I medullary thyroid cancer; drawing shows cancer in the thyroid gland and the tumor is 2 centimeters or smaller. Also shown are the larynx and trachea.
05/15/2017
Cáncer de tiroides medular en estadio I; el dibujo muestra cáncer en la glándula tiroides y el tumor mide 2 cm o menos. También se muestran la laringe y la tráquea.
05/15/2017
Stage II medullary thyroid cancer; drawing shows (a) cancer in the thyroid gland and the tumor is larger than 2 centimeters and (b) cancer has spread to tissues just outside the thyroid gland. Also shown are the larynx and trachea.
05/15/2017
Cáncer de tiroides medular en estadio II; el dibujo muestra: a) cáncer en la glándula tiroides y el tumor mide más de 2 cm; y b) cáncer que se diseminó a los tejidos ubicados justo fuera de la glándula tiroides. También se muestra la laringe y la tráquea.
05/15/2017
Stage III medullary thyroid cancer; drawing shows cancer that has spread to tissues just outside the thyroid gland and to lymph nodes near the trachea and larynx.
05/15/2017
Cáncer de tiroides medular en estadio III; el dibujo muestra cáncer que se diseminó hasta los tejidos ubicados justo fuera de la glándula tiroides y los ganglios linfáticos cerca de la tráquea y la laringe.
05/15/2017
Stage IVA medullary thyroid cancer; drawing shows cancer that has spread from the thyroid gland to the larynx, the esophagus, the left recurrent laryngeal nerve, the trachea, and a lymph node on one side of the neck. Also shown is the right recurrent laryngeal nerve.
05/15/2017
Cáncer de tiroides medular en estadio IVA; el dibujo muestra cáncer que se diseminó desde la glándula tiroides hasta la laringe, el esófago, el nervio laríngeo recurrente izquierdo, la tráquea y un ganglio linfático en un lado del cuello. También se muestra el nervio laríngeo recurrente derecho.
05/15/2017
Stage IVB medullary thyroid cancer; drawing shows cancer that has spread from the thyroid gland to tissue in front of the spine and has surrounded the common carotid artery and the blood vessels in the area between the lungs. Also shown are the internal jugular vein, lymph nodes, and trachea.
05/15/2017
Cáncer de tiroides medular en estadio IVB; el dibujo muestra cáncer que se diseminó desde la glándula tiroides hasta el tejido ubicado delante de la espina vertebral y el cáncer rodea la artería carótida común y los vasos sanguíneos del área entre los pulmones. También se muestra la vena yugular interna, los ganglios linfáticos y la tráquea.
05/15/2017
Stage IVC medullary thyroid cancer; drawing shows other parts of the body where thyroid cancer may spread, including the lymph nodes, lung, and bone. An inset shows cancer cells spreading from the thyroid, through the blood and lymph system, to another part of the body where metastatic cancer has formed.
05/15/2017
Cáncer de tiroides medular en estadio IVC; el dibujo muestra otras partes del cuerpo donde es posible que el cáncer de tiroides se disemine, entre ellas, los ganglios linfáticos, el pulmón y el hueso. El recuadro muestra las células cancerosas que se están diseminando desde la glándula tiroides, a través del sistema sanguíneo y linfático, hasta otra parte del cuerpo en donde el cáncer metastásico se formó.