Breaking News
December 10, 2018 - UC San Diego professor receives NCI Outstanding Investigator Award for cancer research
December 10, 2018 - Study evaluates placental mesenchymal stem cell sheets for myocardial repair and regeneration
December 10, 2018 - Blueprint Medicines Announces Updated Results from Ongoing EXPLORER Clinical Trial of Avapritinib Demonstrating Broad Clinical Activity and Significant Symptom Reductions in Patients with Systemic Mastocytosis
December 10, 2018 - Study clarifies ApoE4’s role in dementia
December 10, 2018 - Neuronal activity in the brain allows prediction of risky or safe decisions
December 10, 2018 - FDA Alerts Health Care Professionals and Patients Not to Use Drug Products Intended to be Sterile from Promise Pharmacy
December 10, 2018 - Improving dementia care and treatment saves thousands of pounds in care homes
December 10, 2018 - Heroin-assisted treatment can offer benefits, reduce harms
December 10, 2018 - People covered by Michigan’s expanded Medicaid program report improvements in health, finds study
December 10, 2018 - Hazelnuts improve micronutrient levels in older adults
December 9, 2018 - History of Partner Violence Tied to Menopause Symptoms
December 9, 2018 - Clean Up Safely After a Disaster|Natural Disasters and Severe Weather
December 9, 2018 - Drug wholesalers drove fentanyl’s deadly rise, report concludes
December 9, 2018 - Deprescribing could help manage polypharmacy in older adults
December 9, 2018 - Retraction of article “Joy of cooking too much” from journal
December 9, 2018 - FDA Warns of Rare Stroke Risk With MS Drug Lemtrada (Alemtuzumab)
December 9, 2018 - Feds say heroin, fentanyl remain biggest drug threat to US
December 9, 2018 - Eliminating microglia can reverse some aspects of stress sensitization, study shows
December 9, 2018 - New genetic insight could help treat rare debilitating heart and lung condition
December 9, 2018 - MiRagen Therapeutics Announces Final Safety, Biodistribution and Clinical Efficacy Data From Phase 1 Cobomarsen Clinical Trial in Patients With Mycosis Fungoides
December 9, 2018 - Work with your doctor to weigh pros, cons of treatment options for hyperthyroidism
December 9, 2018 - CWRU researcher secures $14.6 million funding for genetic study into Alzheimer’s disease
December 9, 2018 - High intensity statin treatment and adherence could save more lives
December 9, 2018 - Surgery patients use only 1/4 of prescribed opioids, and prescription size matters
December 9, 2018 - AXT offers Phi Optics upgrade to QPI systems for inverted light microscopes
December 9, 2018 - New booklet could help improve conditions of young pupils with albinism
December 9, 2018 - Few Physicians Work in Practices That Use Telemedicine
December 9, 2018 - Older Adults and Oral Health
December 9, 2018 - Health utility values improve after septorhinoplasty
December 9, 2018 - New EU-funded project provides insight into how the brain develops
December 9, 2018 - Expanded use of tele-emergency services can help strengthen rural hospitals
December 9, 2018 - Infections in the Young May Be Tied to Risk for Mental Illness: Study
December 9, 2018 - Profile: Native Hawaiians and Pacific Islanders
December 9, 2018 - Snoring poses greater cardiac risk to women
December 9, 2018 - Researcher takes further steps in understanding how and why cute aggression occurs
December 9, 2018 - Researchers create new light-activated tools for controlling neurons
December 9, 2018 - Spinal cord injury disrupts the body’s internal clock, study shows
December 9, 2018 - Babies recognize nested structures similar to our grammar
December 9, 2018 - UT Austin researcher receives $2.5 million CZI grant for neurodegenerative disease research
December 9, 2018 - Sleep problems found to be prevalent and increasing among college students
December 9, 2018 - Study reveals why some children are susceptible to the effects of maltreatment
December 9, 2018 - Study investigates influence of different opioids on driving performance
December 9, 2018 - Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating JZP-258 for the Treatment of Idiopathic Hypersomnia
December 9, 2018 - Eliminating microglia prevents heightened immune sensitivity after stress
December 9, 2018 - Boys with social difficulties are at greatest risk of early substance use
December 9, 2018 - ‘Wrong’ connective tissue cells linked to worse prognosis in breast cancer patients
December 8, 2018 - Chronic, refractory schizophrenia patients benefit from targeted cognitive training
December 8, 2018 - Advertising in kids’ apps more prevalent than parents may realize
December 8, 2018 - New way to trace the transmission histories of rare genetic diseases
December 8, 2018 - ASH: A+CHP Bests CHOP for Peripheral T-Cell Lymphoma
December 8, 2018 - Results of pediatric genomic epilepsy tests often reclassified
December 8, 2018 - New way of controlling HIV latency to completely eradicate the virus
December 8, 2018 - Phasefocus to showcase the Livecyte 2 at ASCB
December 8, 2018 - KHN’s ‘What the Health?’ Is health spending the next big political issue?
December 8, 2018 - Mussels take in microplastic pollution fibers and flush most of them out again
December 8, 2018 - AHA: How to Stop Smoking … for Good
December 8, 2018 - Scientists overturn odds to make Parkinson’s discovery
December 8, 2018 - Health benefits of producing marula vinegar
December 8, 2018 - Failure of critical cellular energy sensor responsible for CKD progression, study finds
December 8, 2018 - Ethnicity can be reliable indicator of gut microbiota diversity
December 8, 2018 - Safe Sleep for Baby | NIH News in Health
December 8, 2018 - Study looks at ways technology can support nutritional needs of Parkinson’s patients
December 8, 2018 - Infant milk allergy is being overdiagnosed say experts
December 8, 2018 - Graphene may one day be used to test for ALS
December 8, 2018 - Houston Methodist launches real-time website to track flu cases
December 8, 2018 - RedHill Announces Positive Top-Line Results from Confirmatory Phase 3 Study with Talicia for H. pylori Infection
December 8, 2018 - A way to measure obesity and health beyond BMI
December 8, 2018 - New diagnostic tools may help identify breast cancer patients who could benefit from targeted therapies
December 8, 2018 - Duke-NUS researchers highlight possible role of bioaerosol sampling in pandemic surveillance
December 8, 2018 - Study quantifies links between alcohol, drug use and violent deaths
December 8, 2018 - Mothers’ stress levels at conception linked to child’s response to life challenges at age 11
December 8, 2018 - MIT researchers develop antimicrobial peptides from South American wasp’s venom
December 8, 2018 - Obesity prevention among low-income, diverse preschool-aged children and parents
December 8, 2018 - Mount Sinai researcher awarded $2.5 million to advance understanding of neurodegenerative diseases
December 8, 2018 - CZI announces funding for open-source software efforts to improve image analysis in biomedicine
December 8, 2018 - New book encompasses the vast history of reproduction
December 8, 2018 - Low-income women in Texas are not receiving contraception after childbirth, study shows
December 8, 2018 - Study expands knowledge about sexuality and gender gaps in political attitudes
December 8, 2018 - Drug reduces hot flash frequency, improves quality of life in breast cancer survivors
December 8, 2018 - Imaging, Biopsy Often Still Needed After Mastectomy
NCCN adds COPIKTRA capsules to NCCN Guidelines for follicular lymphoma

NCCN adds COPIKTRA capsules to NCCN Guidelines for follicular lymphoma

image_pdfDownload PDFimage_print

Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the National Comprehensive Cancer Network® (NCCN®) added COPIKTRA™ (duvelisib) capsules to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for follicular lymphoma (FL).

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. The U.S. Food and Drug Administration (FDA) granted accelerated approval to COPIKTRA on September 24, 2018, for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies. The indication in FL is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Based on data from the Phase 2 DYNAMO™ trial evaluating duvelisib, the NCCN Guidelines now include a Category 2A recommendation for use of COPIKTRA for adult patients whose disease is relapsed or refractory after treatment with at least two prior systemic therapies. The Category 2A recommendation indicates that based upon lower-level evidence, there is uniform NCCN consensus that COPIKTRA is appropriate for these patients.1

“We are pleased that the NCCN has added COPIKTRA to their updated guidelines, which are recognized as an important resource for clinicians and other healthcare decision makers”, said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. “We believe COPIKTRA’s inclusion illustrates its importance as an additional therapy option for relapsed or refractory patients suffering from FL.”

Use of COPIKTRA is associated with a BOXED WARNING for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. Verastem Oncology is implementing an informational Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.

Additionally, use of COPIKTRA is also associated with adverse reactions which may require dose reduction, treatment delay or discontinuation of COPIKTRA. WARNINGS AND PRECAUTIONS are provided for infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity. The most common ADVERSE REACTIONS (reported in ≥ 20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

Please see important Safety Information provided below and Prescribing Information including BOXED WARNING and Medication Guide at www.COPIKTRAHCP.com/prescribinginformation .

COPIKTRA Indication and Usage in FL

COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies.

COPIKTRA Clinical Trials

Efficacy in Relapsed or Refractory FL

Efficacy of COPIKTRA in patients with previously treated FL is based on a single-arm, multicenter trial (DYNAMO™; NCT01882803).

In DYNAMO, COPIKTRA 25 mg BID was administered in patients with FL (N = 83) who were refractory to rituximab and to either chemotherapy or radioimmunotherapy. Refractory disease was defined as less than a partial remission or relapse within 6 months after the last dose. The trial excluded patients with Grade 3b FL, large cell transformation, prior allogeneic transplant, and prior exposure to a PI3K inhibitor or to a Bruton’s tyrosine kinase inhibitor.

The median age was 64 years (range: 30 to 82 years), 68% were male, and 37% had bulky disease assessed at baseline (target lesion ≥ 5 cm). Patients had a median of 3 prior lines of therapy (range: 1 to 10), with 94% being refractory to their last therapy and 81% being refractory to 2 or more prior lines of therapy. Most patients (93%) had an ECOG performance status of 0 or 1.

The median duration of exposure to COPIKTRA was 5 months (range: 0.4 to 24), with 41% of patients receiving at least 6 months and 10% receiving at least 12 months of COPIKTRA.

Efficacy was based on overall response rate and duration of response as assessed by an IRC, as shown below.

Source:

http://investor.verastem.com/phoenix.zhtml?c=250749&p=irol-newsArticle&ID=2370557

Tagged with:

About author

Related Articles