News

NORTH CHICAGO, Ill., April 6, 2023 – AbbVie (NYSE: ABBV) announced today the intent to voluntarily withdraw, in the U.S., accelerated IMBRUVICA^® (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
 
Other approved indications for IMBRUVICA in the U.S. are not affected. This voluntary action is due to requirements related to the accelerated approval status granted by the U.S. FDA for MCL and MZL. These indications were approved via this pathway based on overall response rates in Phase 2 clinical studies. To confirm clinical benefit following accelerated approvals, additional studies are required by the FDA.

The Phase 3 SHINE (NCT01776840) study in previously untreated MCL and the Phase 3 SELENE study (NCT01974440) in relapsed or refractory MZL served as confirmatory studies. The SHINE study met its primary endpoint of progression-free survival.  The addition of IMBRUVICA to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm. The SHINE study results were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine.  The SELENE study did not meet its primary endpoint of progression-free survival. The SELENE study results will be presented at a future scientific forum.

IMBRUVICA's established clinical profile in other approved indications is unchanged and the medication remains the most comprehensively studied and prescribed cancer treatment in its class. IMBRUVICA remains an important therapy for patients and healthcare professionals around the world.

“We pursued accelerated approvals for MCL and MZL indications for IMBRUVICA in the U.S. to offer a treatment to patients who at the time had limited therapeutic options. While we are disappointed in the outcome of the confirmatory trials for these indications, we remain confident in the benefit/risk profile of IMBRUVICA for patients living with multiple forms of blood cancer around the world,” said Roopal Thakkar, senior vice president, chief medical officer, AbbVie.

AbbVie fully supports the FDA accelerated approval process and is working with the FDA to complete these withdrawals. Healthcare professionals in the U.S. should consider the withdrawal of these indications in their treatment plans for patients with MCL and MZL currently taking IMBRUVICA. We are committed to supporting patients who are currently benefiting from IMBRUVICA therapy.

About IMBRUVICA^®
IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. It is approved in more than 100 countries and has been used to treat more than 270,000 patients worldwide. IMBRUVICA blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, IMBRUVICA^® may help move abnormal B cells out of their nourishing environments and inhibits their proliferation.[i]^,[ii],[iii] There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, more than 11 years evaluating the efficacy and safety of IMBRUVICA^®. For more information, visit www.IMBRUVICA.com. Please click here to see the full Prescribing Information.
 
IMPORTANT SAFETY INFORMATION

Before taking IMBRUVICA^®, tell your healthcare provider about all of your medical conditions, including if you:

• have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA^® for any planned medical, surgical, or dental procedure.
• have bleeding problems
• have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes
• have an infection
• have liver problems
• are pregnant or plan to become pregnant. IMBRUVICA^® can harm your 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 pregnant or think you may be pregnant during treatment with IMBRUVICA^®.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA^® and for 1 month after the last dose.
  • Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA^® and for 1 month after the last dose.
• are breastfeeding or plan to breastfeed.  Do not breastfeed during treatment with IMBRUVICA^® and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA^® with certain other medicines may affect how IMBRUVICA^® works and can cause side effects.

How should I take IMBRUVICA^®?

• Take IMBRUVICA^® exactly as your healthcare provider tells you to take it.
• Take IMBRUVICA^® 1 time a day at about the same time each day.

IMBRUVICA^® comes as capsules, tablets, and oral suspension.
 

• If your healthcare provider prescribes IMBRUVICA^® capsules or tablets:
  • Swallow IMBRUVICA^® capsules or tablets whole with a glass of water.
  • Do not open, break, or chew IMBRUVICA^® capsules.
  • Do not cut, crush, or chew IMBRUVICA^® tablets.
• If your healthcare provider prescribes IMBRUVICA^® oral suspension:
  • See the detailed Instructions for Use that comes with IMBRUVICA^® oral suspension for information about the correct way to give a dose to your child. If you have questions about how to give IMBRUVICA^® oral suspension, talk to your healthcare provider.
  • Do not use if the carton seal is broken or missing.
• If you miss a dose of IMBRUVICA^® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA^® at your regular time on the next day. Do not take extra doses of IMBRUVICA^® to make up for a missed dose.
• If you take too much IMBRUVICA^® call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking IMBRUVICA^®?

• You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during 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 side effects, including:
 

• Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA^®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
• Infections can happen during treatment with IMBRUVICA^®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA^®.
• Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death have happened in people treated with IMBRUVICA^®, especially in people who have an infection, an increased risk for heart disease, or have had heart rhythm problems in the past. Your heart function will be checked before and during treatment with IMBRUVICA^®. Tell your healthcare provider if you get any symptoms of 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. If you develop any of these symptoms, your healthcare provider may do tests to check your heart and may change your IMBRUVICA^® dose.
• High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA^®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA^®, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
• Second primary cancers. New cancers have happened during treatment with IMBRUVICA^®, including cancers of the skin or other organs.
• Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

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

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

 
The most common side effects of IMBRUVICA^® in adults or children 1 year of age and older with cGVHD include:

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

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

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

General information about the safe and effective use of IMBRUVICA^®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA^® for a condition for which it was not prescribed. Do not give IMBRUVICA^® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA^® that is written for health professionals.

Please see the full Important Product Information.

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

• Adults with mantle cell lymphoma (MCL) who have received at least one prior treatment.
• Adults with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
• Adults with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
• Adults with Waldenström's macroglobulinemia (WM).
• Adults with marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment.
• Adults and children 1 year of age and older with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy.

It is not known if IMBRUVICA^® is safe and effective in children under 1 year of age.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
 
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for 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 to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency.
2 Turetsky A, et al. Single cell imaging of Bruton's tyrosine kinase using an irreversible inhibitor. Scientific Reports. 2014;6:4782.
3 de Rooij MF, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.

Contact(s)

Contacts:

Media
Ilke Limoncu
ilke.limoncu@abbvie.com

Investors 
Liz Shea
elizabeth.shea@abbvie.com

Physicians
U.S. Medical Information
Phone: 877-877-3536


IMBRUVICA is a registered trademark of Pharmacyclics LLC. SOURCE AbbVie Inc.