NORTH CHICAGO, Ill., Dec. 2, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the results of up to seven years of clinical trial follow-up for IMBRUVICA® (ibrutinib) monotherapy in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the longest follow-up for a Bruton's tyrosine kinase (BTK) inhibitor to date. The updated Phase 1b/2 data demonstrated durable responses in CLL/SLL patients with an overall response rate (ORR) of 89 percent. Evaluated patients included those with high-risk genomic factors such as complex karyotype and unmutated IGHV, and more than 70 patients with three to 12 prior lines of therapy. Progression-free survival (PFS) rates were also sustained (estimated seven-year rates of 80% for previously untreated patients; 32% in the highly pre-treated relapsed/refractory [R/R] groups). The analysis also found that PFS trended better for R/R patients when treated with ibrutinib in earlier lines of therapy (after one or two prior lines of therapy versus three or more lines of prior therapy).

NORTH CHICAGO, Ill., Dec. 1, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company today presented updated data from the pivotal Phase 3 MURANO trial of venetoclax (VENCLEXTA® or VENCLYXTO®) in combination with rituximab (VenR). The results at median follow-up of 36 months demonstrated that the majority of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), treated with VenR, did not experience disease progression or death (PFS; the time on treatment without disease progression or death2) after all patients completed the fixed duration of therapy and stopped treatment, compared to patients treated with a standard of care regimen of bendamustine plus rituximab (BR).1 The estimated PFS rate at 36 months was 71.4 percent (95% confidence interval [CI]: 0.64, 0.78) for patients treated with VenR compared with 15.2 percent (95% CI: 0.09, 0.21) for patients who completed treatment with a standard of care combination of BR (hazard ratio [HR]: 0.16; 95% CI: 0.12, 0.23).1 The data were presented today during the 60th American Society of Hematology (ASH) Annual Meeting & Exposition.

NORTH CHICAGO, Ill., Nov. 21, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VENCLEXTA® (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.7

NORTH CHICAGO, Ill., Nov. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that data from nearly 40 abstracts, including 13 oral presentations and more than 20 poster presentations, will be presented during the upcoming 60th ASH Annual Meeting & Exposition, December 1-4, in San Diego.

NORTH CHICAGO, Ill., Nov. 1, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the European Commission (EC) has approved the type-II variation application for VENCLYXTO® (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. This approval allows more patients to receive VENCLYXTO in the second-line setting and gives healthcare providers the ability to prescribe this medicine to a broader population of patients with R/R CLL than the previously approved indication for VENCLYXTO as monotherapy in the European Union (EU). The approval is valid in all 28 member states of the EU, as well as Iceland, Liechtenstein and Norway.

NORTH CHICAGO, Ill., Oct. 31, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from CLL14, a Phase 3, randomized clinical trial evaluating venetoclax plus obinutuzumab versus obinutuzumab plus chlorambucil, a standard of care, in patients with chronic lymphocytic leukemia (CLL) and coexisting medical conditions who have not received a prior treatment. The study met its primary endpoint of investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death1) with a 12-month fixed duration of treatment. Preliminary analysis suggests the safety profile observed in the combination of venetoclax plus obinutuzumab is consistent with the known safety profile of each medicine alone.

NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the sNDA is approved, the use of IMBRUVICA with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL. IMBRUVICA is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab (BR).1 IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

Whether young or old, age matters in acute myeloid leukemia. Two doctors discuss why.

NORTH CHICAGO, Ill., Sept. 21, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO® (venetoclax tablets) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

NORTH CHICAGO, Ill., Sept. 11, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has expanded the label for VENCLEXTA® (venetoclax tablets) in combination with rituximab to include information about patients with previously-treated chronic lymphocytic leukemia (CLL) who achieved minimal residual disease (MRD)-negativity in the Phase 3 MURANO trial.