Secura Bio Announces New Data To Be Presented At The American Society Of Hematology
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ASH
SUMMERLIN, Nev., Dec. 6, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that several abstracts relating to the Secura Bio product COPIKTRA® (duvelisib) will be presented at the 63rd annual meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
These abstracts feature new data from important ongoing or recently completed clinical trials, including:
Duvelisib in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma from the Phase 2 Primo Trial: Results of an Interim Analysis (click on title to see full abstract)
This abstract will be presented by Dr. Jonathan Brammer on Sunday, December 12, 2021: 6:00 PM-8:00 PM Hall B5 (Georgia World Congress Center).
The Combination of Duvelisib and Romidepsin (DR) Is Highly Active Against Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Final Results and Biomarker Analysis (click on title to see full abstract)
This abstract will be presented by Dr. Steven Horwitz on Monday, December 13, 2021: 10:30 AM-12:00 PM Hall A1 (Georgia World Congress Center).
TEMPO: A Phase 2, Randomized, Open-Label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL) (click on title to see full abstract)
This abstract will be presented by Dr. Vladimir Vorobyev on Monday, December 13, 2021: 6:00 PM-8:00 PM Hall B5 (Georgia World Congress Center).
"The presentations of new data for COPIKTRA at ASH reflect the dedication of Secura Bio and the researchers with whom we work to develop products for the treatment of challenging hematologic malignancies in patients with important unmet needs." said Joseph M. Limber, President and CEO of Secura Bio.
About COPIKTRA (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment. COPIKTRA is indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track designation in the United States. COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full prescribing information for complete boxed warning
INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:
Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
Please click here to see full U.S. Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib).
To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Secura Bio at 1-800-9SECURA (1-844-973-2872).
About Secura Bio, Inc.
Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit www.securabio.com
Related Linkshttps://www.securabio.com
SOURCE Secura Bio, Inc.
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