COPIKTRA® (duvelisib) Receives European Union Marketing Authorization for the Treatment of Relapsed or Refractory CLL and Refractory FL
LAS VEGAS, June 9, 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 on May 19, 2021 the European Medicines Agency granted marketing authorization for COPIKTRA as monotherapy for the treatment of relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in patients, who have received at least two prior therapies and for the treatment of Follicular Lymphoma (FL) that is refractory to at least two prior systemic therapies.
CLL and FL are slow-growing incurable blood cancers that can lead to life-threatening complications such as anemia, serious infections, and bone marrow failure requiring treatment. The goal of therapy for patients with these cancers is to improve overall survival and quality of life. COPIKTRA is a dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation of malignant cells and are thought to play a role in the formation and maintenance of the supportive tumor microenvironment.
"This market authorization is an important step in helping patients suffering from relapsed or refractory CLL and FL who currently have limited options and poor outcomes. When commercially launched, COPIKTRA will provide patients and physicians across much of Europe with an oral, dual inhibitor of phosphoinositide 3-kinases (PI3K), a treatment option that works differently from other available therapies for these incurable diseases." said Dr. David Cohan, Chief Medical Officer of Secura Bio.
"With the market authorization of COPIKTRA in the European Union, Secura Bio will have two meaningful oncology drugs with novel modes of action. This is another step forward toward fulfilling our corporate goal: to expand our portfolio of indications worldwide for the treatment of challenging hematologic and solid malignancies in patients with important unmet needs." said Joseph M. Limber, President and CEO of Secura Bio.
"COPIKTRA provides European physicians and patients with another valuable and beneficial option to combat these debilitating illnesses. We are now working hard with the haematology community and relevant authorities to ensure COPIKTRA is widely reimbursed and commercially launched across Europe, providing much needed access for patients suffering with CLL and FL" said Erik Bokmans, Vice President and General Manager, Europe
About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic lymphocytic leukemia (CLL) is a cancer that affects lymphocytes with most of the cancer cells located in the bloodstream and/or the bone marrow, although the lymph nodes and spleen are often involved. The symptoms of CLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL will live for years without symptoms. There are approximately 250,000 patients in the EU affected by CLL, with nearly 25,000 new diagnoses expected this year alone. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to commonly used agents, or are unable to tolerate treatment -- generating significant unmet medical needs. The potential of effective new oral agents, particularly those that can be used as monotherapies in the community setting, offer hope in the treatment of patients with CLL.
About Follicular Lymphoma
Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a "B-cell lymphoma." FL accounts for 20 to 30 percent of all NHL cases, affecting more than 180,000 people in the EU, with more than 16,500, newly diagnosed cases expected this year. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin; as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at the time of diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients often living for many years following diagnosis. New oral agents that can be added to the community hematologist's/oncologist's s armamentarium, particularly monotherapies, may offer significant benefit in the treatment of patients with FL.
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, and has accelerated approval for refractory follicular lymphoma (FL) after at least two prior systemic 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
- Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
- Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
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.
- Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate; continued approval may be contingent upon confirmatory trials.
WARNINGS AND PRECAUTIONS
- Hepatotoxicity: Monitor hepatic function.
- Neutropenia: Monitor blood counts.
- Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
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
- CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
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
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