– If approved by the European Commission (EC), VENCLYXTO® plus rituximab would be the first chemotherapy-free combination regimen with a fixed duration of treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy.
– The positive opinion is based on the MURANO Phase 3 clinical trial, in which VENCLYXTO plus rituximab met the primary endpoint of prolonged progression-free survival and the majority of patients achieved undetectable minimal residual disease in the peripheral blood, compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab.[1]
– The safety profile of the combination of VENCLYXTO plus rituximab is consistent with the known safety profile of each medicine alone.[1]
NORTH CHICAGO, IL, USA I September 21, 2018 I 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.
In 2016, VENCLYXTO was approved by the EC as a monotherapy for the treatment of R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. If approved by the EC, VENCLYXTO plus rituximab could be prescribed to a broader patient population with R/R CLL than the currently approved indication for VENCLYXTO monotherapy in the EU.
“This positive CHMP opinion is one important step forward as AbbVie continues to further the research and development of novel medicines with the potential to transform the standard of care in blood cancers,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The combination of VENCLYXTO with rituximab has the potential to give patients with relapsed/refractory chronic lymphocytic leukemia a chance to live longer without their disease progressing, and to stop treatment after their two-year course.”
The CHMP positive opinion is based on results from the MURANO Phase 3 clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared with bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death2) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.1
In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint assessed at the end of combination therapy (nine-month assessment). The majority of patients in the trial who received VENCLYXTO plus rituximab achieved uMRD in the peripheral blood.1 Undetectable minimal residual disease, is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.2
“The venetoclax plus rituximab combination has the potential to be truly transformative for patients with relapsed/refractory CLL,” said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of Cancer Medicine at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. “The progression-free survival observed in the MURANO trial, and the fixed duration of treatment that may allow patients to stop treatment, are encouraging developments with the potential to advance the care and management of patients with relapsed/refractory CLL.”
CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3 CLL accounts for approximately one third of new leukemia diagnoses.4
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
About the MURANO Trial
A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized, Phase 3 MURANO trial. The trial was designed to evaluate the efficacy and safety of VENCLYXTO in combination with rituximab (N=194) compared with bendamustine in combination with rituximab (N=195). The median age of patients in the trial was 65 years (range: 22-85).1
The primary efficacy endpoint was investigator (INV)-assessed PFS. Additional efficacy endpoints included independent review committee (IRC)-assessed PFS, INV- and IRC-assessed overall response rate (defined as complete response + complete response with incomplete marrow recovery + partial response + nodular partial response), overall survival, and rates of uMRD.1
About VENCLYXTO® (venetoclax tablets)
VENCLEXTA® (VENCLYXTO® in the EU) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other cancerous tumors, BCL-2 builds up and prevents cancer cells from undergoing their natural death or self-destruction process, which is called apoptosis. VENCLEXTA targets the BCL-2 protein and works to restore the process of apoptosis.
VENCLEXTA/ VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.
VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S. AbbVie and Roche are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
SOURCE: AbbVie
Post Views: 135
– If approved by the European Commission (EC), VENCLYXTO® plus rituximab would be the first chemotherapy-free combination regimen with a fixed duration of treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy.
– The positive opinion is based on the MURANO Phase 3 clinical trial, in which VENCLYXTO plus rituximab met the primary endpoint of prolonged progression-free survival and the majority of patients achieved undetectable minimal residual disease in the peripheral blood, compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab.[1]
– The safety profile of the combination of VENCLYXTO plus rituximab is consistent with the known safety profile of each medicine alone.[1]
NORTH CHICAGO, IL, USA I September 21, 2018 I 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.
In 2016, VENCLYXTO was approved by the EC as a monotherapy for the treatment of R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. If approved by the EC, VENCLYXTO plus rituximab could be prescribed to a broader patient population with R/R CLL than the currently approved indication for VENCLYXTO monotherapy in the EU.
“This positive CHMP opinion is one important step forward as AbbVie continues to further the research and development of novel medicines with the potential to transform the standard of care in blood cancers,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The combination of VENCLYXTO with rituximab has the potential to give patients with relapsed/refractory chronic lymphocytic leukemia a chance to live longer without their disease progressing, and to stop treatment after their two-year course.”
The CHMP positive opinion is based on results from the MURANO Phase 3 clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared with bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death2) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.1
In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint assessed at the end of combination therapy (nine-month assessment). The majority of patients in the trial who received VENCLYXTO plus rituximab achieved uMRD in the peripheral blood.1 Undetectable minimal residual disease, is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.2
“The venetoclax plus rituximab combination has the potential to be truly transformative for patients with relapsed/refractory CLL,” said Prof. John Seymour, MBBS, Ph.D., lead investigator of the MURANO trial and Director of Cancer Medicine at the Peter MacCallum Cancer Centre & Royal Melbourne Hospital in Australia. “The progression-free survival observed in the MURANO trial, and the fixed duration of treatment that may allow patients to stop treatment, are encouraging developments with the potential to advance the care and management of patients with relapsed/refractory CLL.”
CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3 CLL accounts for approximately one third of new leukemia diagnoses.4
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
About the MURANO Trial
A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized, Phase 3 MURANO trial. The trial was designed to evaluate the efficacy and safety of VENCLYXTO in combination with rituximab (N=194) compared with bendamustine in combination with rituximab (N=195). The median age of patients in the trial was 65 years (range: 22-85).1
The primary efficacy endpoint was investigator (INV)-assessed PFS. Additional efficacy endpoints included independent review committee (IRC)-assessed PFS, INV- and IRC-assessed overall response rate (defined as complete response + complete response with incomplete marrow recovery + partial response + nodular partial response), overall survival, and rates of uMRD.1
About VENCLYXTO® (venetoclax tablets)
VENCLEXTA® (VENCLYXTO® in the EU) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other cancerous tumors, BCL-2 builds up and prevents cancer cells from undergoing their natural death or self-destruction process, which is called apoptosis. VENCLEXTA targets the BCL-2 protein and works to restore the process of apoptosis.
VENCLEXTA/ VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.
VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S. AbbVie and Roche are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, LinkedIn or Instagram.
SOURCE: AbbVie
Post Views: 135
