fda report stroke for patient on chemotherapy

Stroke occurred in 44 (0.75%) and 51 (0.39%) patients in the chemotherapy and nonchemotherapy group, respectively. Kaplan-Meier curve analysis showed that patients in the chemotherapy group had a higher stroke risk than those in the nonchemotherapy group (hazard ratio [HR] 1.84; 95% confidence interval [CI] 1.23-2.75).

Full Answer

What is the risk of a stroke from chemotherapy?

In general, the risk of a chemotherapy-induced stroke is rather low and the risk is higher for some specific regimens, such as methotrexate (MTX), 5-fluorouracil, cisplatin and L-asparaginase (4,71).

Is there a role for antithrombotic therapy in cancer-associated stroke?

An alternative antithrombotic paradigm for cancer-associated stroke is antiplatelet therapy, which is the mainstay for most strokes, easy to administer, and generally safe.

What are the treatment options for cancer patients with acute stroke?

Endovascular therapy is another treatment option for cancer patients with acute stroke but there are no trial data in this population.

Is intravenous thrombolysis safe for stroke patients with brain tumors?

However, intravenous thrombolysis may be carefully considered in stroke patients with benign brain tumors, particularly if small and extraaxial.65 Endovascular therapy is another treatment option for cancer patients with acute stroke but there are no trial data in this population.

What is the present review of stroke?

The present review focuses on the possible pathophysiological mechanisms and causes of stroke in cancer patients, and aims to identify the most common and specific types of stroke. Moreover, clinical manifestations are discussed, and useful modalities to diagnose the cause of stroke in cancer patients are presented, while providing valuable information on treatment and prevention measures.

What causes a stroke in cancer patients?

In general, hypercoagulopathy or other coagulation disorders are most often related to the development of ischemic/embolic stroke (9,15,19). Cardio-embolism, large-vessel atherosclerosis and small-vessel occlusion have been reported as the major causes of ischemic stroke, while non-bacterial thrombotic endocarditis (NBTE) is rarely noted (9,17). In the pathogenesis and prognosis of acute ischemic stroke, active cancer (recurrent malignant tumor, metastases, or ongoing chemo-/radiotherapy) plays an active role (1). In survivors of childhood Hodgkin's disease, who are at an increased risk for stroke, mantle radiation exposure is strongly associated with subsequent stroke and the potential mechanisms may include carotid artery disease or cardiac valvular disease (14). Nevertheless, brain tumors always remain the main etiology for stroke or other neurological pathologies, while cases where the diagnostic misinterpretation of a brain tumor as a stroke or the diagnostic misinterpretation of an underlying malignancy as an incident of CVD, are not rare (13).

What is the connection between stroke and cancer?

The connection between stroke and cancer has for long captivated the interest of the medical community . The first large autopsy study was conducted in 1985 by Graus et al, showing that the most frequent complication of the central nervous system (CNS) in cancer patients, following metastasis, was cerebral infarction and hemorrhage. In the same study, 14.6% of cancer patients had pathological evidence of CVD and approximately half of them were symptomatic (11). More recent studies, such as that among Hodgkin lymphoma 5-year survivors, demonstrated that 7% of patients developed an ischemic stroke in the 17.5-year follow-up period (12).

Where is the 14Laboratory of Toxicology located?

14Laboratory of Toxicology, School of Medicine, University of Crete, 71003 Heraklion, Greece

Where is the 2 Department of Neurology located?

2Department of Neurology, University Hospital of Ioannina, 45110 Ioannina

Is Creative Commons a non-commercial license?

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

What is the CDER approved therapy for?

CDER approved a new therapy to help raise excessively low levels of phosphate in the blood (induced by a specific type of tumor) in certain patients with osteomalacia (softening of the bones).

How many drugs will be fast tracked in 2020?

CDER designated 17 of the 53 novel drugs (32%) in 2020 as Fast Track. Fast Track speeds new drug development and review by increasing the level of communication between FDA and drug developers, and by enabling CDER to review portions of a drug application ahead of the submission of the complete application.

What is Farxiga used for?

Farxiga (dapagliflozin), tablets, originally approved by CDER in 2014 as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults with type 2 diabetes.

What is breakthrough therapy?

Breakthrough therapies are drugs for serious or life-threatening diseases for which there is unmet medical need and for which there is preliminary clinical evidence demonstrating that the drug may result in substantial improvement on a clinically significant endpoint (usually an endpoint that reflects how the patient feels, functions or survives) over other available therapies. CDER designated 22 of the 53 novel drugs (42%) in 2020 as breakthrough therapies. A breakthrough therapy designation includes all the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program. Breakthrough therapy designation is designed to help shorten the development time of potentially important new therapies.

How many breakthrough drugs will be available in 2020?

CDER designated 22 of the 53 novel drugs (42%) in 2020 as breakthrough therapies. A breakthrough therapy designation includes all the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program.

What is the new treatment for juvenile arthritis?

In 2020, CDER approved two new therapies for the treatment of polyarticular juvenile idiopathic arthritis, a type of juvenile arthritis (arthritis in children) that causes inflammation in five or more joints within the first six months of the disease. CDER also approved a new therapy for pediatric patients with ulcerative colitis, a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops open sores, or ulcers. Additionally, CDER approved a new therapy to treat patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype (trait)—the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

What is a new formulation?

A new formulation of a drug is one in which the product’s active ingredient is already FDA-approved. New formulations of already-approved drugs can offer significant advances in therapy. Below are notable new formulations as well as other notable non-novel drug approvals of 2020, including, but not limited to, those with a new combination of active ingredients or a new manufacturer of an already FDA-approved drug.

What is Padcev approved for?

Padcev (enfortumab vedotin-ejfv) injection, approved under FDA’s accelerated approval program to treat refractory bladder cancer. Refractory means a type of cancer that does not respond well to treatment.

What type of cancer is CDER approved for?

CDER also approved a new therapy for patients with mantle cell lymphoma, also a form of blood cancer. CDER also approved a new treatment for a certain type of myelofibrosis, in which the bone marrow is replaced by scar tissue and is not able to make healthy blood cells.

What is the first treatment for lupus?

In 2019, CDER approved the first therapy to treat children with systemic lupus erythematosus –- a serious chronic disease that causes inflammation and damage to various body tissues and organs. We also approved the first FDA-approved treatment for certain adults with a type of inflammatory arthritis called non-radiographic axial spondyloarthritis, an autoimmune condition that causes inflammation in the spine and other symptoms. 2019 also saw the first FDA approval of a treatment specifically for pediatric patients --- ages 6 to 17 years of age --- with Lambert-Eaton myasthenic syndrome, a disease that can cause muscle weakness in the body’s limbs and eyes as well as those used for talking and swallowing, making walking, and self-care difficult. We also approved the first pediatric treatment for granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), in combination with glucocorticoids (steroid hormones); GPA and MPA are diseases in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them.

What is breakthrough therapy?

Breakthrough therapies are drugs for serious or life-threatening diseases for which there is unmet medical need and for which there is preliminary clinical evidence demonstrating that the drug may result in substantial improvement on a clinically significant endpoint (usually an endpoint that reflects how the patient feels, functions or survives) over other available therapies. CDER designated 13 of the 48 novel drugs (27%) in 2019 as breakthrough therapies. A breakthrough therapy designation includes all the Fast Track program features, as well as more intensive FDA guidance on an efficient drug development program. Breakthrough therapy designation is designed to help shorten the development time of potentially important new therapies.

What type of cancer is diffuse large B cell?

Also to help advance cancer therapies, CDER approved a new drug to treat certain adult patients with diffuse large B-cell lymphoma, the most common type of non-Hodgkin lymphoma, a type of blood cancer. CDER also approved a new therapy for patients with mantle cell lymphoma, also a form of blood cancer.

What is CDER in medicine?

In 2019, FDA’s Center for Drug Evaluation and Research’s (CDER’s) new drug therapy approvals helped a wide range of patients suffering from many different medical conditions gain new hope for improved quality of life, and in some cases, improved chances of surviving life-threatening illnesses.

Why are novel drugs important?

Novel drugs often represent important new therapies for advancing patient care. Importantly, this report also goes beyond a discussion of novel approvals and includes an overview of an array of other notable approvals --- for instance, new approvals for uses of already FDA-approved drugs.

What is the Division of Neurological and Physical Medicine Devices?

To further enable stroke device development and movement to the marketplace, the Division of Neurological and Physical Medicine Devices is a primary component within CDRH that supports moving safe and effective medical devices to the marketplace. For example, CDRH has taken an active approach to make these pathways more transparent to the public, including hosting a number of neurological device-based webinars focused on different regulatory pathways. 8 This series of webinars has helped to increase the knowledge and familiarity for Sponsors and Investigators in moving their products through the regulatory process and included discussions of the IDE, 9 Premarket Approval, 10 and de novo 11 submissions. FDA has also attended and hosted public meetings to enable direct communication between the Agency and multiple stakeholders in the stroke field, such as at Stroke Treatment Academic Industry Roundtable conferences 12 and the 2015 AIS public workshop. 13 Additionally, FDA has authored publications 14 as well as developed a website dedicated to neurological devices 15 to provide an avenue to learn about the Agency and to make more transparent how to get medical devices to patients.

How long after stroke can you use a stent?

The FDA continues to work with medical device manufacturers in the field of stroke. Recently, a series of mechanical stent-retriever clot removal devices were cleared for a new treatment claim associated with the reduction of disability in stroke patients, such as paralysis and speech difficulties. These devices are labeled to be used in patients with a smaller core, persistent, large vessel occlusion in the proximal anterior circulation within 6 hours of symptom onset, and only following on-label treatment with IV tPA, which needs to be given within 3 hours of symptom onset. 3 The FDA evaluated data from a clinical trial comparing 96 randomly selected patients treated with a neurothrombectomy device along with IV tPA and medical management of blood pressure and disability symptoms with 249 patients who had only IV tPA and medical management. 3 Twenty-nine percent of patients treated with the neurothrombectomy device were functionally independent (ranging from no symptoms to slight disability) 90 days after their stroke, compared with 19% of patients who were not treated with a device.

How does the FDA market stroke devices?

Many paths to market for stroke devices include collecting clinical data. FDA may review clinical and statistical data, which could be collected both within the United States or OUS, to make a marketing authorization decision. In the clearance for the first mechanical neurothrombectomy device for a treatment indication, FDA reviewed an OUS multicenter study. FDA recognizes that Sponsors may choose to conduct multinational clinical studies under a variety of scenarios, including United States and OUS sites, and FDA will review all information submitted. To consider whether OUS study data applies to the US population, FDA may ask for example, do the OUS human subject protection standards meet FDA’s applicable requirements?; are there differences between the OUS and United States clinical conditions, regulatory expectations, and study populations such that the data would not be sufficient to support the safety and effectiveness of the studied device?; and can the data submitted be adequately translated to the outcomes that one would see in US patients and constitutes valid scientific evidence.

What is the FDA's premarket approval for stroke devices?

There are many pathways available to bring a medical device to market ( Table) including the Premarket Approval application, typically reserved for the highest risk devices that must demonstrate a reasonable assurance of both safety and effectiveness; the Premarket Notification (510 (k)) pathway, reserved for low- to moderate-risk devices that provide performance data to demonstrate that they are as safe and effective as another device already on the market with similar technological characteristics for use in the same intended patient population; and de novo classification for low to moderate-risk devices for which there is no comparable class II or class I device already on the market with similar technological characteristics and the same intended use. A device granted through the de novo pathway creates a new regulation and serves as a predicate device for the 510 (k) pathway for future devices if classified in class II. In a stroke, there are a number of devices available such as mechanical neurothrombectomy devices and aspiration catheters, which received marketing authorization using the 510 (k) and de novo regulatory pathways. The FDA has also approved 2 Humanitarian Device Exemptions for intracranial stent systems for the treatment of symptomatic and medically refractory intracranial atherosclerotic disease, relevant to stroke and addressing a vulnerable patient population. The Humanitarian Device Exemption pathway is an alternative regulatory pathway for rare diseases defined as conditions or disease that affects no more 8000 individuals per year in the United States in which the Sponsor must demonstrate safety and probable benefit of their device for the indicated patient population.

What is the CDRH?

The Center for Devices and Radiological Health (CDRH), a core component of FDA, is committed to fostering the development of high-quality, safe, and effective medical devices of public health importance and to facilitating greater patient access to these technologies.

What is the importance of enabling new treatments to reach the marketplace?

Enabling new treatments to reach the marketplace requires valid scientific evidence and a regulatory process that can accelerate promising new treatments. This process is critical to alleviating the heavy disease burden of stroke in the United States. This article reviews medical device regulation, premarket and postmarket evaluation of devices indicated for stroke and cerebrovascular disease and provides a staff perspective on the future development of these devices.

Why are additional options needed for stroke patients?

Additional options are still needed for stroke patients and their families, especially because of the emergent time dependence of intervention to affect clinical outcomes. A large part of the equation involves the continued development of novel treatments that are reasonably safe and effective. A second significant part of the equation is that promising treatments reach the US marketplace in an expeditious fashion, which requires a dialog with FDA and device manufacturers. Defining the most appropriate subjects for individual treatments, conducting those studies either United States or OUS, use of one or multiple devices during the treatment, and using all sources of available information (eg, registry data) to make the best regulatory decisions require important questions to be addressed all the while allowing the devices to continue to evolve. Devices requesting expanded approved indications compared to what is currently on label (or shown to be safe and effective in prior studies) may require additional investigation to offer subjects additional treatment options where current options are limited. Other factors to consider in the evolution of medical devices include trial design, greater familiarity by Sponsors and Principal Investigators with the regulatory landscape for neurological devices, and opening direct lines of communication with FDA.