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Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.
"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"
Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.
The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.
Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.
Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.
Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.
Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.
Pomalidomide is marketed by Celgene.
On Twitter @maryjodales
Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.
"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"
Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.
The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.
Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.
Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.
Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.
Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.
Pomalidomide is marketed by Celgene.
On Twitter @maryjodales
Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.
"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"
Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.
The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.
Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.
Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.
Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.
Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.
Pomalidomide is marketed by Celgene.
On Twitter @maryjodales
