– Milestone represents ninth FDA approval for IMBRUVICA in less than five years since its initial approval
– New approval of IMBRUVICA plus rituximab for Waldenström’s macroglobulinemia (WM) is supported by recent Phase 3 study data that showed a 30-month progression-free survival rate of 82 percent for patients on the combination therapy, versus 28 percent for patients on rituximab alone
– Following Priority Review from the U.S. FDA, approval of the use of IMBRUVICA plus rituximab for adult patients with WM was received nearly two months in advance of anticipated date
– IMBRUVICA now has a total of nine FDA approvals across six different diseases
NORTH CHICAGO, II, USA I August 27, 2018 I AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in January 2015. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
“We are pleased to have IMBRUVICA approved, both as a single agent and combination therapy with rituximab, to provide an additional efficacious treatment option for people living with Waldenström’s macroglobulinemia,” said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company. “We are proud of our robust clinical development program, and this new approval reflects our continuous commitment to exploring the full potential of IMBRUVICA’s mechanism of action for treating patients with diseases that have great unmet medical need.”
This new FDA approval is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA in combination with rituximab, versus rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM. At a median follow up of 26.5 months, the study demonstrated a significant improvement in progression-free survival (PFS) with IMBRUVICA plus rituximab compared to rituximab alone (30-month PFS rates were 82 percent versus 28 percent, respectively). Patients taking IMBRUVICA plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab (hazard ratio, 0.20; confidence interval: 0.11-0.38, P<0.0001). These data were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting and simultaneously published in The New England Journal of Medicine.
“The iNNOVATE study demonstrated persuasive clinical evidence supporting the efficacy of IMBRUVICA plus rituximab in Waldenström’s macroglobulinemia,” said Dr. Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and lead iNNOVATE study investigator.* “This approval is a significant milestone for the WM community who have limited treatment options.”
“Ibrutinib has significantly advanced the treatment of Waldenström’s macroglobulinemia. The approval of ibrutinib and rituximab has added a new option for many Waldenström’s patients,” said Steven P. Treon, M.D., Ph.D., Director of the Bing Center for Waldenström’s Macroglobulinemia at the Dana-Farber Cancer Institute, Associate Professor at Harvard Medical School, and lead investigator of the IMBRUVICA Phase 2 clinical trial which served as the basis for its January 2015 FDA approval.*
WM is a rare, slow-growing and incurable form of NHL with limited treatment options. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen also may be affected. In the U.S., there are about 2,800 new cases of WM each year.1
The most common adverse reactions (occurring in 20% or more of patients) of all Grades in patients treated with IMBRUVICA plus rituximab in the iNNOVATE study were bruising (37%), musculoskeletal pain (35%), hemorrhage (32%), diarrhea (28%), rash (24%), arthralgia (24%), nausea (21%), and hypertension (20%).
In combination with rituximab or as a single agent, the recommended dose of IMBRUVICA for adults with WM is 420 mg taken orally once daily until disease progression or unacceptable toxicity. When administering IMBRUVICA in combination with rituximab, consider administering IMBRUVICA prior to rituximab when given on the same day.
About iNNOVATE
iNNOVATE is a Pharmacyclics-sponsored, randomized, placebo-controlled, double-blind, Phase 3 study, which enrolled 150 patients with relapsed/refractory and treatment-naïve Waldenström’s macroglobulinemia. Patients were randomized to receive intravenous rituximab 375 mg/m2 once weekly for four consecutive weeks, followed by a second four-weekly rituximab course following a three-month interval. All patients received either ibrutinib 420 mg or placebo once daily continuously until criteria for permanent discontinuation were met. The primary endpoint was progression-free survival, with secondary endpoints including overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment, overall survival, and number of participants with adverse events as a measure of safety and tolerability within each treatment arm.
About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host disease (cGVHD).3
- IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in January 2015.
- In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously-treated CLL/SLL.
- In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
- In August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.
- In August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.4 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, 100,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.
1 Lymphoma Research Foundation. Getting the facts: Waldenström macroglobulinemia. https://www.lymphoma.org/wp-content/uploads/2017/06/LRF_FACTSHEET_Waldenstro%CC%88m_Macroglobulinemia.pdf. Accessed August 2018.
2 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed August 2018.
3 IMBRUVICA U.S. Prescribing Information, August 2018
4 U.S. Food and Drug Administration. Fact sheet: breakthrough therapies. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed August 2018.
SOURCE: AbbVie
Post Views: 267
– Milestone represents ninth FDA approval for IMBRUVICA in less than five years since its initial approval
– New approval of IMBRUVICA plus rituximab for Waldenström’s macroglobulinemia (WM) is supported by recent Phase 3 study data that showed a 30-month progression-free survival rate of 82 percent for patients on the combination therapy, versus 28 percent for patients on rituximab alone
– Following Priority Review from the U.S. FDA, approval of the use of IMBRUVICA plus rituximab for adult patients with WM was received nearly two months in advance of anticipated date
– IMBRUVICA now has a total of nine FDA approvals across six different diseases
NORTH CHICAGO, II, USA I August 27, 2018 I AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in January 2015. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
“We are pleased to have IMBRUVICA approved, both as a single agent and combination therapy with rituximab, to provide an additional efficacious treatment option for people living with Waldenström’s macroglobulinemia,” said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company. “We are proud of our robust clinical development program, and this new approval reflects our continuous commitment to exploring the full potential of IMBRUVICA’s mechanism of action for treating patients with diseases that have great unmet medical need.”
This new FDA approval is supported by data from the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA in combination with rituximab, versus rituximab alone, in 150 patients with previously untreated and relapsed/refractory WM. At a median follow up of 26.5 months, the study demonstrated a significant improvement in progression-free survival (PFS) with IMBRUVICA plus rituximab compared to rituximab alone (30-month PFS rates were 82 percent versus 28 percent, respectively). Patients taking IMBRUVICA plus rituximab also experienced an 80 percent reduction in relative risk of disease progression or death than those only treated with rituximab (hazard ratio, 0.20; confidence interval: 0.11-0.38, P<0.0001). These data were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting and simultaneously published in The New England Journal of Medicine.
“The iNNOVATE study demonstrated persuasive clinical evidence supporting the efficacy of IMBRUVICA plus rituximab in Waldenström’s macroglobulinemia,” said Dr. Meletios A. Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and lead iNNOVATE study investigator.* “This approval is a significant milestone for the WM community who have limited treatment options.”
“Ibrutinib has significantly advanced the treatment of Waldenström’s macroglobulinemia. The approval of ibrutinib and rituximab has added a new option for many Waldenström’s patients,” said Steven P. Treon, M.D., Ph.D., Director of the Bing Center for Waldenström’s Macroglobulinemia at the Dana-Farber Cancer Institute, Associate Professor at Harvard Medical School, and lead investigator of the IMBRUVICA Phase 2 clinical trial which served as the basis for its January 2015 FDA approval.*
WM is a rare, slow-growing and incurable form of NHL with limited treatment options. WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen also may be affected. In the U.S., there are about 2,800 new cases of WM each year.1
The most common adverse reactions (occurring in 20% or more of patients) of all Grades in patients treated with IMBRUVICA plus rituximab in the iNNOVATE study were bruising (37%), musculoskeletal pain (35%), hemorrhage (32%), diarrhea (28%), rash (24%), arthralgia (24%), nausea (21%), and hypertension (20%).
In combination with rituximab or as a single agent, the recommended dose of IMBRUVICA for adults with WM is 420 mg taken orally once daily until disease progression or unacceptable toxicity. When administering IMBRUVICA in combination with rituximab, consider administering IMBRUVICA prior to rituximab when given on the same day.
About iNNOVATE
iNNOVATE is a Pharmacyclics-sponsored, randomized, placebo-controlled, double-blind, Phase 3 study, which enrolled 150 patients with relapsed/refractory and treatment-naïve Waldenström’s macroglobulinemia. Patients were randomized to receive intravenous rituximab 375 mg/m2 once weekly for four consecutive weeks, followed by a second four-weekly rituximab course following a three-month interval. All patients received either ibrutinib 420 mg or placebo once daily continuously until criteria for permanent discontinuation were met. The primary endpoint was progression-free survival, with secondary endpoints including overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment, overall survival, and number of participants with adverse events as a measure of safety and tolerability within each treatment arm.
About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host disease (cGVHD).3
- IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
- Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
- IMBRUVICA was approved for adult patients with WM in January 2015.
- In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously-treated CLL/SLL.
- In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
- In August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.
- In August 2018, IMBRUVICA plus rituximab was approved for adult patients with WM.
Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.4 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. To date, 100,000 patients around the world have been treated with IMBRUVICA in clinical practice and clinical trials.
1 Lymphoma Research Foundation. Getting the facts: Waldenström macroglobulinemia. https://www.lymphoma.org/wp-content/uploads/2017/06/LRF_FACTSHEET_Waldenstro%CC%88m_Macroglobulinemia.pdf. Accessed August 2018.
2 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed August 2018.
3 IMBRUVICA U.S. Prescribing Information, August 2018
4 U.S. Food and Drug Administration. Fact sheet: breakthrough therapies. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed August 2018.
SOURCE: AbbVie
Post Views: 267
