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The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for elotuzumab (Empliciti).
With this sBLA, Bristol-Myers Squibb Company is seeking approval for elotuzumab in combination with pomalidomide and low-dose dexamethasone to treat patients with relapsed/refractory multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.
The FDA expects to make a decision on the sBLA for elotuzumab by December 27, 2018.
Elotuzumab is already FDA-approved for use in combination with lenalidomide and dexamethasone to treat MM patients who have received one to three prior therapies.
Bristol-Myers Squibb and AbbVie are co-developing elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.
Supporting trial
The sBLA for elotuzumab is supported by data from ELOQUENT-3, a randomized, phase 2 study in which researchers evaluated the addition of elotuzumab to pomalidomide and low-dose dexamethasone in patients with relapsed/refractory MM.
Data from this study were presented at the 23rd Congress of the European Hematology Association in June.
The trial randomized 117 MM patients who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor.
The patients were randomized to receive either elotuzumab, pomalidomide, and low-dose dexamethasone (EPd; n=60) or pomalidomide and low-dose dexamethasone (Pd; n=57) in 28-day cycles until disease progression or unacceptable toxicity.
The overall response rate was 53% in the EPd arm and 26% in the Pd arm (odds ratio=3.25; P=0.0029).
The median progression-free survival was 10.3 months in the EPd arm and 4.7 months in the Pd arm (hazard ratio=0.54, P=0.0078).
Overall survival data were not mature at last follow-up, but there was a trend favoring EPd over Pd (hazard ratio=0.62).
The researchers said adverse events (AEs) in the EPd arm were consistent with expectations based on previous results with elotuzumab and pomalidomide regimens.
Grade 3-4 nonhematologic AEs (in the EPd and Pd arms, respectively) included constipation (2% and 0%), hyperglycemia (8% and 7%), bone pain (3% and 0%), dyspnea (3% and 2%), fatigue (0% and 4%), respiratory tract infection (0% and 2%), and upper respiratory tract infection (0% and 2%).
Grade 3-4 hematologic AEs (in the EPd and Pd arms, respectively) included anemia (10% and 20%), neutropenia (13% and 27%), thrombocytopenia (8% and 5%), and lymphopenia (8% and 2%).
Grade 3-4 AEs of special interest (in the EPd and Pd arms, respectively) included infections (13% and 22%), vascular disorders (3% and 0%), cardiac disorders (7% and 4%), and neoplasms (2% and 11%).
In the EPd arm, grade 5 AEs included infection (n=3), cardiac failure (n=1), and general physical health deterioration (n=1).
In the Pd arm, grade 5 AEs included malignant neoplasm progression (n=4), infection (n=1), multiple organ failure and infection (n=1), myocardial infarction (n=1), and plasma cell myeloma (n=1).
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for elotuzumab (Empliciti).
With this sBLA, Bristol-Myers Squibb Company is seeking approval for elotuzumab in combination with pomalidomide and low-dose dexamethasone to treat patients with relapsed/refractory multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.
The FDA expects to make a decision on the sBLA for elotuzumab by December 27, 2018.
Elotuzumab is already FDA-approved for use in combination with lenalidomide and dexamethasone to treat MM patients who have received one to three prior therapies.
Bristol-Myers Squibb and AbbVie are co-developing elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.
Supporting trial
The sBLA for elotuzumab is supported by data from ELOQUENT-3, a randomized, phase 2 study in which researchers evaluated the addition of elotuzumab to pomalidomide and low-dose dexamethasone in patients with relapsed/refractory MM.
Data from this study were presented at the 23rd Congress of the European Hematology Association in June.
The trial randomized 117 MM patients who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor.
The patients were randomized to receive either elotuzumab, pomalidomide, and low-dose dexamethasone (EPd; n=60) or pomalidomide and low-dose dexamethasone (Pd; n=57) in 28-day cycles until disease progression or unacceptable toxicity.
The overall response rate was 53% in the EPd arm and 26% in the Pd arm (odds ratio=3.25; P=0.0029).
The median progression-free survival was 10.3 months in the EPd arm and 4.7 months in the Pd arm (hazard ratio=0.54, P=0.0078).
Overall survival data were not mature at last follow-up, but there was a trend favoring EPd over Pd (hazard ratio=0.62).
The researchers said adverse events (AEs) in the EPd arm were consistent with expectations based on previous results with elotuzumab and pomalidomide regimens.
Grade 3-4 nonhematologic AEs (in the EPd and Pd arms, respectively) included constipation (2% and 0%), hyperglycemia (8% and 7%), bone pain (3% and 0%), dyspnea (3% and 2%), fatigue (0% and 4%), respiratory tract infection (0% and 2%), and upper respiratory tract infection (0% and 2%).
Grade 3-4 hematologic AEs (in the EPd and Pd arms, respectively) included anemia (10% and 20%), neutropenia (13% and 27%), thrombocytopenia (8% and 5%), and lymphopenia (8% and 2%).
Grade 3-4 AEs of special interest (in the EPd and Pd arms, respectively) included infections (13% and 22%), vascular disorders (3% and 0%), cardiac disorders (7% and 4%), and neoplasms (2% and 11%).
In the EPd arm, grade 5 AEs included infection (n=3), cardiac failure (n=1), and general physical health deterioration (n=1).
In the Pd arm, grade 5 AEs included malignant neoplasm progression (n=4), infection (n=1), multiple organ failure and infection (n=1), myocardial infarction (n=1), and plasma cell myeloma (n=1).
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for elotuzumab (Empliciti).
With this sBLA, Bristol-Myers Squibb Company is seeking approval for elotuzumab in combination with pomalidomide and low-dose dexamethasone to treat patients with relapsed/refractory multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.
The FDA expects to make a decision on the sBLA for elotuzumab by December 27, 2018.
Elotuzumab is already FDA-approved for use in combination with lenalidomide and dexamethasone to treat MM patients who have received one to three prior therapies.
Bristol-Myers Squibb and AbbVie are co-developing elotuzumab, with Bristol-Myers Squibb solely responsible for commercial activities.
Supporting trial
The sBLA for elotuzumab is supported by data from ELOQUENT-3, a randomized, phase 2 study in which researchers evaluated the addition of elotuzumab to pomalidomide and low-dose dexamethasone in patients with relapsed/refractory MM.
Data from this study were presented at the 23rd Congress of the European Hematology Association in June.
The trial randomized 117 MM patients who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor.
The patients were randomized to receive either elotuzumab, pomalidomide, and low-dose dexamethasone (EPd; n=60) or pomalidomide and low-dose dexamethasone (Pd; n=57) in 28-day cycles until disease progression or unacceptable toxicity.
The overall response rate was 53% in the EPd arm and 26% in the Pd arm (odds ratio=3.25; P=0.0029).
The median progression-free survival was 10.3 months in the EPd arm and 4.7 months in the Pd arm (hazard ratio=0.54, P=0.0078).
Overall survival data were not mature at last follow-up, but there was a trend favoring EPd over Pd (hazard ratio=0.62).
The researchers said adverse events (AEs) in the EPd arm were consistent with expectations based on previous results with elotuzumab and pomalidomide regimens.
Grade 3-4 nonhematologic AEs (in the EPd and Pd arms, respectively) included constipation (2% and 0%), hyperglycemia (8% and 7%), bone pain (3% and 0%), dyspnea (3% and 2%), fatigue (0% and 4%), respiratory tract infection (0% and 2%), and upper respiratory tract infection (0% and 2%).
Grade 3-4 hematologic AEs (in the EPd and Pd arms, respectively) included anemia (10% and 20%), neutropenia (13% and 27%), thrombocytopenia (8% and 5%), and lymphopenia (8% and 2%).
Grade 3-4 AEs of special interest (in the EPd and Pd arms, respectively) included infections (13% and 22%), vascular disorders (3% and 0%), cardiac disorders (7% and 4%), and neoplasms (2% and 11%).
In the EPd arm, grade 5 AEs included infection (n=3), cardiac failure (n=1), and general physical health deterioration (n=1).
In the Pd arm, grade 5 AEs included malignant neoplasm progression (n=4), infection (n=1), multiple organ failure and infection (n=1), myocardial infarction (n=1), and plasma cell myeloma (n=1).