• The U. S. Food and Drug Administration approved the use of IMBRUVICA for the treatment of pediatric patients one year and older with cGVHD after failure of one or more lines of systemic therapy
  • This is the first approved treatment option for children with cGVHD under 12 years of age plus the only Bruton’s tyrosine kinase inhibitor (BTKi) therapy for a pediatric patient population
  • cGVHD is a rare condition that can occur in patients after receiving peripheral blood or bone marrow stem cell transplantation often related to blood cancer treatment
  • IMBRUVICA was the particular first treatment approved in the Oughout. S. within 2017 for adult individuals with cGVHD after failure of 1 or more lines of systemic therapy

NORTH CHICAGO, Ill. , Aug. 24, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U. S. Food and Drug Administration (FDA) authorized the use of IMBRUVICA ® (ibrutinib) with regard to the remedying of pediatric sufferers one year and older with chronic graft versus host disease (cGVHD) right after failure associated with one or even more lines of systemic treatment.

The approval is AbbVie’s first pediatric indication regarding IMBRUVICA, marking the twelve th FDA approval for IMBRUVICA and the particular first Bruton’s tyrosine kinase inhibitor (BTKi) treatment accepted for a pediatric patient population. This authorization also marks the first approved treatment option for kids under 12 years associated with age suffering from cGVHD. The approval is primarily based on positive results from the iMAGINE Phase 1/2 clinical trial.

cGVHD occurs when donated peripheral blood or bone marrow stem cells view the recipient’s body as foreign and the donated cells launch an immune attack on the entire body. 1   cGVHD impacts major organs, including the particular skin, eyes, mouth plus liver as the most commonly affected. About 35% of the estimated 8, 000 patients who undergo life-saving allogeneic hematopoietic originate cell transplant (HSCT) per year develop cGVHD that requires systemic therapy. one   Additionally, cGVHD is the particular most common cause of morbidity after an allogeneic transplant. Steroids are the current standard treatment for pediatric cGVHD. 4

“For a substantial fraction of children who create moderate or even severe persistent graft compared to host illness after bloodstream or marrow transplantation, treatment options supported by methodical, formal study in children are usually limited, ” said Dr. Paul A. Carpenter , attending physician at Seattle Children’s Hospital and a study principal investigator. “Now, healthcare professionals have another effective treatment choice for both pediatric and adult individuals living along with this condition after failing of just one or more ranges of systemic therapy. Additionally , having an oral suspension formulation designed for children is a helpful alternative. ”

“This approval will be incredibly meaningful as AbbVie’s first pediatric approval intended for IMBRUVICA as well as within our company’s oncology portfolio. As a Pediatric Oncologist, whenever my sufferers describe the physical pain they experience from simply hugging their parents due to their cGVHD, the importance of researching option treatment options in this individual population is usually further validated, ” said Gauri Sunkersett, D. O., associate medical director at AbbVie. “At AbbVie, we are committed to driving oncology research plus developing therapies that possess the potential to help patients of all ages, including underserved populations like children diagnosed with cGVHD. inch

The iMAGINE study demonstrated an Overall Response Rate (ORR) through week 25 associated with 60% (Confidence Interval [CI] 95%; 44-74) in individuals median age 13 years (range, 1-19 years) (n=47) with relapsed/refractory (R/R) moderate to severe cGVHD. 5 The particular median duration of response was 5. 3 months (95% CI: 2. 8, eight. 8). 5 Safety was consistent with the particular established profile for IMBRUVICA, with observed adverse reactions (ARs) constant with those observed within adult sufferers with reasonable to serious cGVHD. 5 The most typical ARs (occurring in 20% or more of patients), which includes laboratory abnormalities, were anemia, musculoskeletal discomfort, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache. five

Since  2017 , IMBRUVICA has been authorized as the single-agent therapy for adult patients along with cGVHD who have experienced failure associated with prior systemic therapy, becoming the 1st FDA-approved therapy for cGVHD.

“In some ways, kids struggling with cGVHD have been a good ‘orphan population’ in relation to having treatments available. Although there offers been progress in accepted treatment choices for adults with cGVHD, the safety plus efficacy of these have not been well studied in children, ” said Susan Stewart , executive director of BMT InfoNet, a non-profit advocacy organization to get bone marrow, stem cell and cord blood hair transplant patients. “This FDA acceptance of IMBRUVICA gives children and their families struggling along with this very difficult disease newfound hope. ”

The particular recommended dose of IMBRUVICA for cGVHD patients twelve years and older is definitely 420 mg taken orally once daily until illness progression or even unacceptable toxicity. 6 In cGVHD patients one year old in order to less than 12 many years of age group, the recommended dose associated with IMBRUVICA can be 240 mg/m two taken by mouth once every day (up to a dose of 420 mg) until disease progression or unacceptable toxicity. 6 This FDA approval also includes an oral suspension formulation of IMBRUVICA to provide an alternative plus child-friendly administration option.

About the think about Study 5
iMAGINE ( PCYC-1146-IM ) is an open-label, multi-center, single-arm trial of IMBRUVICA pertaining to the treatment of pediatric and young grownup patients aged one 12 months to less than 22 years with moderate or severe cGVHD as defined by NIH Consensus Criteria. The study included 47 patients that required additional therapy right after failure associated with one or even more prior outlines of systemic therapy. Patients aged 12 years plus older were treated along with IMBRUVICA 420 mg orally once everyday, and patients aged a single year in order to less compared to 12 years were treated with IMBRUVICA 240 mg/m 2 orally once daily. Primary endpoints included pharmacokinetics (PK) and safety, and secondary endpoints included  overall response rate (ORR; CR/PR) for each 2014 NIH criteria, overall survival, and duration of response (DOR).

About  IMBRUVICA ®
IMBRUVICA ® (ibrutinib) is an once-daily dental medication that is jointly developed plus commercialized simply by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. IMBRUVICA ® blocks the particular Bruton’s tyrosine kinase (BTK) protein, which is needed by normal plus abnormal B cells, including specific malignancy cells, to multiply and spread. By blocking BTK, IMBRUVICA ® may help move abnormal B tissues out associated with their nourishing environments plus inhibits their own proliferation. 7, 7, 9

IMBRUVICA ® is certainly approved within more than 100 countries and provides been used to treat more compared to 250, 000 patients worldwide. There are a lot more than 50 company-sponsored medical trials, which includes 18 Stage 3 studies, over 11 years evaluating the efficacy and security of IMBRUVICA ® .

IMBRUVICA ® was very first approved by the U. S. Food and Medication Administration (FDA) in November 2013 , and today is indicated for mature patients in six condition areas, including five hematologic cancers. These include indications to treat adults with CLL/SLL with or without 17p deletion (del17p), adults with Waldenström’s macroglobulinemia (WM), adults along with previously handled mantle cellular lymphoma (MCL)*, adult individuals with previously treated marginal zone lymphoma (MZL) who else require systemic therapy and have received at least one prior anti-CD20-based therapy*, and also adult and pediatric sufferers with formerly treated chronic graft vs host disease (cGVHD) after failure of one or more lines of systemic treatment. six  

*Accelerated approval was granted meant for MCL plus MZL dependent on general response rate. Continued authorization for MCL and MZL may be contingent upon verification and description associated with clinical benefit in confirmatory trials.

Since 2019, the National Comprehensive Cancer Network ® (NCCN ® ), recommends ibrutinib (IMBRUVICA ® ) because a preferred regimen for the initial remedying of CLL/SLL and has Category 1 treatment status for treatment-naïve patients without deletion 17p/ TP53 mutation and as a favored treatment designed for treatment-naïve patients with removal 17p/ TP53 mutation. The NCCN Guidelines ® also recommend IMBRUVICA ® , without or with rituximab, as a preferred regimen for the particular treatment of relapsed/refractory MCL, since a Category 1 preferred regimen just for both untreated and earlier treated WM patients, so that as a preferred regimen for relapsed/refractory MZL. 10

For more information, visit www.IMBRUVICA.com .

IMPORTANT SAFETY   INFORMATION

Before taking IMBRUVICA ® , tell your healthcare provider about all of your healthcare conditions, which includes if you:

  • have had recent surgery or even plan to have got surgery. Your doctor may stop IMBRUVICA ® for any planned medical, surgical, or dental procedure.
  • have bleeding problems
  • have or had heart rhythm issues, smoke, or even have the medical condition that increases your risk of coronary heart disease, such as high blood pressure, high cholesterol, or diabetes
  • have an infection
  • possess liver difficulties
  • are pregnant or intend to become expecting. IMBRUVICA ® can harm your own unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA ® . Tell your healthcare provider if you are expectant or think you may be pregnant during therapy with IMBRUVICA ® .
    • Females who are able to become pregnant should use efficient birth control (contraception) during treatment with IMBRUVICA ® plus for 1 month after the last dosage.
    • Males with female partners who are capable to turn out to be pregnant  ought to use effective birth manage, like condoms, during treatment with IMBRUVICA ® and for one month after the last dose.
  • are breastfeeding or even plan in order to breastfeed.   Do not breastfeed during therapy with IMBRUVICA ® as well as for 1 week following the last dosage.

Tell your doctor regarding all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA ® along with certain other medicines might affect how IMBRUVICA ® works and may cause side effects.

How need to I get IMBRUVICA ® ?

  • Take IMBRUVICA ® exactly as your health care provider tells you to consider it.
  • Take IMBRUVICA ® one time a day at about the same time each day.

IMBRUVICA ® comes because capsules, tablets, and mouth suspension.

  • If your healthcare provider prescribes IMBRUVICA ® capsules or pills:
    • Swallow IMBRUVICA ® capsules or tablets whole with a glass of water.
    • Do not open, break, or even chew IMBRUVICA ® capsules.
    • Usually do not cut, crush, or chew IMBRUVICA ® capsules.
  • If your own healthcare provider prescribes IMBRUVICA ® oral suspension:
    • See the detailed Instructions for Use that comes with IMBRUVICA ® oral suspension system for information about the correct way to give a dosage to your child. If you have got questions regarding how to provide IMBRUVICA ® dental suspension, talk to your healthcare supplier.
    • Tend not to make use of if the carton seal is broken or missing.
  • If you miss a dose of IMBRUVICA ® take it since soon as you remember on the particular same day. Take your own next dose of IMBRUVICA ® at your regular time upon the next day. Do not take extra doses associated with IMBRUVICA ® to make up for a missed dose.
  • If you take too much IMBRUVICA ® call your health care provider or even go in order to the nearest hospital emergency room right away.

What should I avoid while getting IMBRUVICA ® ?

  • You ought to not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) throughout treatment with IMBRUVICA ® . These products may increase the amount of IMBRUVICA ® in your blood.

What are the possible side effects of IMBRUVICA ® ?
IMBRUVICA ® may cause serious negative effects, including:

  • Bleeding troubles (hemorrhage) are common during treatment with IMBRUVICA ® , and can also become serious and may lead to death. Your own risk of bleeding may increase in case you are also taking a blood thinner medicine. Inform your healthcare service provider if you have any signs of bleeding, including: bloodstream within your stools or black stools (looks like tar), pink or brown urine, unexpected hemorrhaging, or bleeding that is severe or that will you cannot control, vomit blood or even vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or even a headache that lasts a long time or severe headache.
  • Infections can happen during therapy with IMBRUVICA ® . These infections can be serious and might result in death. Tell your healthcare provider right away if a person have fever, chills, some weakness, confusion, or even other signs or symptoms of a good infection during treatment along with IMBRUVICA ® .
  • Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation plus atrial flutter), heart failure and dying have happened in people treated with IMBRUVICA ® , especially in people who have an infection, an increased danger for center disease, or have had cardiovascular rhythm complications in the past. Your heart function will end up being checked prior to and throughout treatment with IMBRUVICA ® . Inform your health care provider if you get any kind of symptoms associated with heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles or legs, chest discomfort, or you faint. In case you develop any of these symptoms, your own healthcare company may perform tests to check your heart and may change your own IMBRUVICA ® dosage.
  • High blood pressure (hypertension). New or worsening high blood pressure has happened within people given IMBRUVICA ® . Your doctor may start you on blood pressure medicine or modify current medications to deal with your stress.
  • Decrease in blood cell counts. Decreased bloodstream counts (white blood tissue, platelets, plus red blood cells) are usually common along with IMBRUVICA ® , but can also be severe. Your own healthcare provider should do monthly blood tests to check your own blood matters.
  • Second primary cancers. New malignancies have occurred during treatment with IMBRUVICA ® , including cancers associated with the skin or some other organs.
  • Tumor lysis syndrome (TLS). TLS will be caused simply by the fast breakdown of cancer cellular material. TLS may cause kidney failure as well as the need with regard to dialysis therapy, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do bloodstream tests in order to check you for TLS.

The most common unwanted effects of IMBRUVICA ® in grown ups with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

  • diarrhea
  • tiredness
  • muscle and bone pain
  • rash
  • bruising

The most common part effects associated with IMBRUVICA ® in adults or kids 1 yr of age plus older with cGVHD include:

  • tiredness
  • low red blood cell count (anemia)
  • bruising
  • diarrhea
  • lower platelet count number
  • muscle and joint pain
  • temperature
  • muscle spasms
  • mouth sores (stomatitis)
  • hemorrhaging
  • nausea
  • stomach pain
  • pneumonia
  • headache

Diarrhea is a common side effect in people which take IMBRUVICA ® . Drink plenty of fluids during treatment along with IMBRUVICA ® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your doctor in case you have diarrhea that does not really go away.

These are not all the particular possible side effects of IMBRUVICA ® . Call your doctor for medical advice about side effects. You may report negative effects in order to FDA in 1-800-FDA-1088.

General information about the safe plus effective use of IMBRUVICA ®
Medicines are sometimes prescribed regarding purposes other than those listed in a Patient Information leaflet. Never use IMBRUVICA ® intended for a condition for which it was not really prescribed. Perform not give IMBRUVICA ® to other people, even if they possess the same symptoms that you have. It may harm them. You can ask your own pharmacist or even healthcare supplier for info about IMBRUVICA ® that is usually written to get health professionals.

Please see the full Important Product Information .

Uses
What is definitely IMBRUVICA ® (ibrutinib)?
IMBRUVICA ® (ibrutinib) is a prescription medicine used to treat:

  • Adults with mantle cell lymphoma (MCL) who have got received from least one particular prior treatment.
  • Adults along with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
  • Adults with persistent lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
  • Grown ups with Waldenström’s macroglobulinemia (WM).
  • Adults with marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and also have received a certain type of prior treatment.
  • Adults and children 1 season old and older along with chronic graft versus host disease (cGVHD) after failing of 1 or more lines of systemic therapy.

It can be not known if IMBRUVICA ® is safe and efficient in kids under 1 year of age.

About AbbVie within Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline associated with investigational treatments across a range of cancer types. Our dedicated and skilled team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating a lot more than 20 investigational medications in over 300 scientific trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are usually devoted to exploring solutions to help patients obtain access in order to our cancer medicines. For more details, please visit http://www.abbvie.com/oncology .

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the healthcare challenges associated with tomorrow. We strive to have a remarkable effect on people’s lives throughout several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s wellness and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. To find out more about AbbVie, please visit us at www.abbvie.com . Follow @abbvie upon Twitter , Facebook , Instagram , YouTube plus LinkedIn .

Forward-Looking Statements
Some statements with this news release are, or may be considered, forward-looking statements pertaining to purposes of the Private Securities Litigation Reform Act of 1995. The words “believe, ” “expect, ” “anticipate, ” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results in order to differ materially from all those indicated in the forward-looking statements. Such risks plus uncertainties consist of, but are not limited to, failure in order to realize the particular expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from additional products, challenges to intellectual property, difficulties inherent within the research and development process, adverse litigation or even government action, changes to laws and regulations applicable to our own industry plus the impact of public health outbreaks, epidemics or pandemics, for example COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that could affect AbbVie’s operations is set forth in Item 1A, “Risk Factors, inch of AbbVie’s 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, because updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation in order to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except since required by law.

IMBRUVICA is the registered trademark of Pharmacyclics LLC.

one Martin PJ, Lee SJ, Przepiorka D, et al. National Institutes of Health Consensus Development Project upon Criteria meant for Clinical Trials in Persistent Graft-versus-Host Illness: VI. The 2014 Clinical Trial Design Working Group Report. Biol Blood Marrow Transplant. 2015; 21(8): 1343-1359. doi: ten. 1016/j. bbmt. 2015. 05. 004.

2 Lee SJ. Classification systems designed for chronic graft-versus-host disease. Blood . 2017; 129(1): 30-37. Doi: 10. 1182/blood-2016-07-686642.

3 Cooke KR, Luznik L, Sarantopoulos S, et al. The particular Biology associated with Chronic Graft-versus-Host Disease: The Task Force Report from your National Institutes of Wellness Consensus Advancement Project on Criteria just for Clinical Tests in Chronic Graft-versus-Host Condition. Biol Bloodstream Marrow Transplant . 2017; 23(2): 211-234. doi: ten. 1016/j. bbmt. 2016. 09. 023.

4 Baird K, Cooke K, Schultz KR. Persistent graft-versus-host illness (GVHD) in children. Pediatr Clin North Am. 2010; 57(1): 297-322. doi: 10. 1016/j. pcl. 2009. eleven. 003.

5 “Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects along with Chronic Graft versus Host Disease (CGVHD) – Full Text View. ” ClinicalTrials. gov, https://clinicaltrials.gov/ct2/show/NCT03790332 . Accessed August 2022.

6 IMBRUVICA ® U. S. Prescribing Information, August 2022.

7 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed July 2022.

8 Turetsky A, ainsi que al. Single cell imaging of Bruton’s tyrosine kinase using an irreversible inhibitor.   Scientific Reviews . 2014; 6: 4782.

nine de Rooij MF, Kuil A, Geest CR, ou al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion plus migration within chronic lymphocytic leukemia.   Blood . 2012; 119(11): 2590-2594.

ten NCCN ®   Medical Practice Guidelines in Oncology (NCCN Recommendations ® ) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V2. 2022. National Comprehensive Cancer Network. Accessed This summer 2022.

SOURCE AbbVie

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