About the Part 3 VERONA Trial
VERONA is a world Part 3 randomized, managed trial evaluating the efficacy and security of venetoclax together with azacitidine in comparison with azacitidine and placebo, within the remedy of newly identified higher-risk myelodysplastic syndrome (higher-risk MDS). The first end result measure is general survival (OS). Key secondary end result measures embrace modified general response (mOR) and full remission (CR).
Extra data could be discovered https://clinicaltrials.gov/study/NCT04401748 .
About VENCLEXTA ® /VENCLYXTO ® (venetoclax)
VENCLEXTA/VENCLYXTO (venetoclax) is a first-in-class medication that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents most cancers cells from present process their pure demise or self-destruction course of, referred to as apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to assist restore the method of apoptosis.
VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It’s collectively commercialized by AbbVie and Genentech, a member of the Roche Group, within the U.S. and by AbbVie exterior of the U.S. Collectively, the businesses are dedicated to BCL-2 analysis and to learning venetoclax in medical trials throughout a number of blood and different cancers. Venetoclax is permitted in additional than 80 nations, together with the U.S.
VENCLEXTA® (venetoclax) U.S. Makes use of and Essential Security Info 2
Makes use of
VENCLEXTA is a prescription medication used:
- to deal with adults with power lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- together with azacitidine, or decitabine, or low-dose cytarabine to deal with adults with newly identified acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or
‒ produce other medical circumstances that stop using customary chemotherapy.
It’s not identified if VENCLEXTA is protected and efficient in kids.
Essential Security Info
What’s a very powerful data I ought to learn about VENCLEXTA?
VENCLEXTA may cause severe unintended effects, together with:
Tumor lysis syndrome (TLS). TLS is brought on by the quick breakdown of most cancers cells. TLS may cause kidney failure, the necessity for dialysis remedy, and should result in demise. Your healthcare supplier will do exams to verify your threat of getting TLS earlier than you begin taking VENCLEXTA. You’ll obtain different medicines earlier than beginning and through remedy with VENCLEXTA to assist cut back your threat of TLS. You may additionally must obtain intravenous (IV) fluids into your vein. Your healthcare supplier will do blood exams to verify for TLS once you first begin remedy and through remedy with VENCLEXTA. It is very important maintain your appointments for blood exams. Inform your healthcare supplier immediately if you happen to have any signs of TLS throughout remedy with VENCLEXTA, together with fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, darkish or cloudy urine, uncommon tiredness, or muscle or joint ache.
Drink loads of water throughout remedy with VENCLEXTA to assist cut back your threat of getting TLS. Drink 6 to eight glasses (about 56 ounces complete) of water every day, beginning 2 days earlier than your first dose, on the day of your first dose of VENCLEXTA, and every time your dose is elevated.
Your healthcare supplier might delay, lower your dose, or cease remedy with VENCLEXTA when you have unintended effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare supplier might once more verify to your threat of TLS and alter your dose.
Who shouldn’t take VENCLEXTA?
Sure medicines should not be taken once you first begin taking VENCLEXTA and whereas your dose is being slowly elevated due to the chance of elevated TLS.
- Inform your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the- counter medicines, nutritional vitamins, and natural dietary supplements. VENCLEXTA and different medicines might have an effect on one another inflicting severe unintended effects.
- Don’t begin new medicines throughout remedy with VENCLEXTA with out first speaking together with your healthcare supplier.
Earlier than taking VENCLEXTA, inform your healthcare supplier about all your medical circumstances, together with if you happen to:
- have kidney or liver issues.
- have issues together with your physique salts or electrolytes, equivalent to potassium, phosphorus, or calcium.
- have a historical past of excessive uric acid ranges in your blood or gout.
- are scheduled to obtain a vaccine. You shouldn’t obtain a “stay vaccine” earlier than, throughout, or after remedy with VENCLEXTA, till your healthcare supplier tells you it’s okay. In case you are unsure about the kind of immunization or vaccine, ask your healthcare supplier. These vaccines is probably not protected or might not work as properly throughout remedy with VENCLEXTA.
- are pregnant or plan to change into pregnant. VENCLEXTA might hurt your unborn child. If you’ll be able to change into pregnant, your healthcare supplier ought to do a being pregnant take a look at earlier than you begin remedy with VENCLEXTA, and you need to use efficient contraception throughout remedy and for 30 days after the final dose of VENCLEXTA. In the event you change into pregnant or assume you’re pregnant, inform your healthcare supplier immediately.
- are breastfeeding or plan to breastfeed. It’s not identified if VENCLEXTA passes into your breast milk. Don’t breastfeed throughout remedy with VENCLEXTA and for 1 week after the final dose.
What ought to I keep away from whereas taking VENCLEXTA?
You shouldn’t drink grapefruit juice or eat grapefruit, Seville oranges (usually utilized in marmalades), or starfruit while you’re taking VENCLEXTA. These merchandise might enhance the quantity of VENCLEXTA in your blood.
What are the doable unintended effects of VENCLEXTA?
VENCLEXTA may cause severe unintended effects, together with:
- Low white blood cell counts (neutropenia). Low white blood cell counts are frequent with VENCLEXTA, however can be extreme. Your healthcare supplier will do blood exams to verify your blood counts throughout remedy with VENCLEXTA and should pause dosing.
- Infections. Loss of life and severe infections equivalent to pneumonia and blood an infection (sepsis) have occurred throughout remedy with VENCLEXTA. Your healthcare supplier will carefully monitor and deal with you immediately when you have a fever or any indicators of an infection throughout remedy with VENCLEXTA.
Inform your healthcare supplier immediately when you have a fever or any indicators of an an infection throughout remedy with VENCLEXTA.
The commonest unintended effects of VENCLEXTA when utilized in mixture with obinutuzumab or rituximab or alone in folks with CLL or SLL embrace low white blood cell counts; low platelet counts; low pink blood cell counts; diarrhea; nausea; higher respiratory tract an infection; cough; muscle and joint ache; tiredness; and swelling of your arms, legs, arms, and toes.
The commonest unintended effects of VENCLEXTA together with azacitidine or decitabine or low-dose cytarabine in folks with AML embrace nausea; diarrhea; low platelet depend; constipation; low white blood cell depend; fever with low white blood cell depend; tiredness; vomiting; swelling of arms, legs, arms, or toes; fever; an infection in lungs; shortness of breath; bleeding; low pink blood cell depend; rash; abdomen (belly) ache; an infection in your blood; muscle and joint ache; dizziness; cough; sore throat; and low blood stress.
VENCLEXTA might trigger fertility issues in males. This will likely have an effect on your skill to father a toddler. Speak to your healthcare supplier when you have issues about fertility.
These will not be all of the doable unintended effects of VENCLEXTA. Name your physician for medical recommendation about unintended effects.
You’re inspired to report unfavourable unintended effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch or name 1-800-FDA-1088.
The total U.S. prescribing data, together with Treatment Information, for VENCLEXTA could be discovered here . Globally, prescribing data varies; check with the person nation product label for full data.
About AbbVie
AbbVie’s mission is to find and ship revolutionary medicines and options that resolve severe well being points right now and tackle the medical challenges of tomorrow. We try to have a outstanding impression on folks’s lives throughout a number of key therapeutic areas – immunology, oncology, neuroscience, and eye care – and services in our Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com . Observe @abbvie on LinkedIn, Fb, Instagram, X (previously Twitter), and YouTube.
About AbbVie in Oncology
At AbbVie, we’re dedicated to reworking requirements of look after sufferers dwelling with difficult-to-treat cancers. We’re advancing a dynamic pipeline of investigational therapies throughout a variety of most cancers sorts in each blood cancers and stable tumors. We’re specializing in creating focused medicines that both impede the copy of most cancers cells or allow their elimination. We obtain this by way of numerous, focused remedy modalities and biology interventions, together with small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and in situ CAR-T platforms. Our devoted and skilled staff joins forces with revolutionary companions to speed up the supply of potential breakthrough medicines.
At this time, our expansive oncology portfolio includes permitted and investigational remedies for a variety of blood and stable tumors. We’re evaluating greater than 20 investigational medicines in a number of medical trials throughout among the world’s most widespread and debilitating cancers. As we work to have a outstanding impression on folks’s lives, we’re dedicated to exploring options to assist sufferers acquire entry to our most cancers medicines. For extra data, please go to http://www.abbvie.com/oncology .
Ahead-Trying Statements
Some statements on this information launch are, or could also be thought of, forward-looking statements for functions of the Non-public Securities Litigation Reform Act of 1995. The phrases “consider,” “count on,” “anticipate,” “mission” and related expressions and makes use of of future or conditional verbs, typically establish forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these expressed or implied within the forward-looking statements. Such dangers and uncertainties embrace, however will not be restricted to, challenges to mental property, competitors from different merchandise, difficulties inherent within the analysis and growth course of, hostile litigation or authorities motion, modifications to legal guidelines and rules relevant to our trade, the impression of world macroeconomic components, equivalent to financial downturns or uncertainty, worldwide battle, commerce disputes and tariffs, and different uncertainties and dangers related to world enterprise operations. Extra details about the financial, aggressive, governmental, technological and different components which will have an effect on AbbVie’s operations is about forth in Merchandise 1A, “Threat Components,” of AbbVie’s 2024 Annual Report on Type 10-Ok, which has been filed with the Securities and Trade Fee, as up to date by its Quarterly Experiences on Type 10-Q and in different paperwork that AbbVie subsequently information with the Securities and Trade Fee that replace, complement or supersede such data. AbbVie undertakes no obligation, and particularly declines, to launch publicly any revisions to forward-looking statements on account of subsequent occasions or developments, besides as required by regulation.
References
1. Research Of Venetoclax Pill With Intravenous or Subcutaneous Azacitidine to Assess Change in Illness Exercise In Grownup Contributors With Newly Recognized Greater-Threat Myelodysplastic Syndrome (Verona). http://clinicaltrials.gov/study/NCT04401748 . Accessed June 10, 2025 .
2. VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL. : AbbVie Inc.
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SOURCE AbbVie