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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

XULTOPHY 100/3.6 may affect the way some medicines work and some medicines may affect the way XULTOPHY 100/3.6 works.

- Novel BCL-2 inhibitor, approved as a single agent, provided 80 percent overall response rate in Phase 2 clinical study in patients with 17p deletion(1) - Important new treatment option for patients with difficult to treat form of CLL(2) - The approval of Venclexta reinforces Abb Vie's growing position in hematologic oncology /PRNewswire/ -- Abb Vie (NYSE: ABBV), a global biopharmaceutical company, today announced the U. Food and Drug Administration (FDA) has granted accelerated approval of Venclexta™ (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. "The FDA's approval of Venclexta marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed/refractory CLL who harbor the 17p deletion," said , chairman of the board and chief executive officer of Abb Vie. "Results from the clinical trial program show that Venclexta provides significant overall response among previously treated patients with CLL with 17p deletion," said , and a leading principal clinical investigator in the Venclexta clinical trial program.

"With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer." CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called lymphocytes become cancerous and multiply abnormally.

The FDA also granted venetoclax three Breakthrough Therapy designations – the first for venetoclax for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation,, Abb Vie announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for venetoclax for the treatment of patients with CLL with 17p deletion or TP53 mutation.

The cookies contain no personally identifiable information and have no effect once you leave the Medscape site.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Approved: November 2016 Please click here for Xultophy® 100/3.6 Prescribing Information, including Boxed Warning.Do not use XULTOPHY 100/3.6 for a condition for which it was not prescribed. About Diabetes In the About Novo Nordisk Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care.Call your doctor for medical advice about side effects.You may report side effects to FDA at 1-800-FDA-1088.




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