A immunomodulating drug.
Pomalyst capsules.
This agent plus low-dose dexamethasone in relapsed multiple myeloma associated with an overall response rate of 68% in patients, some of which were refractory to lenalidomide, suggesting absence of cross-resistance between the 2 immunomodulating drugs (Lacey MQ et al).
Can induce responses even in patients who are lenalidomide resistant or refractory.
Major toxicity is myelosuppressiom.
Approved for the treatment of patients with multiple myeloma in patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The approval was based on the results of clinical trial CC-4047-MM-002; a multicenter, randomized, open-label study in 221 patients with relapsed and refractory multiple myeloma who had previously received lenalidomide and bortezomib and were refractory to the last myeloma therapy.
In the above study the treatment arms were pomalidomide alone or pomalidomide plus low-dose dexamethasone: efficacy results demonstrated an overall response rate of 7% in patients treated with pomalidomide alone, and 29% in those treated with pomalidomide plus low-dose dexamethasone.
The median response duration was 7.4 months in the pomalidomide plus low-dose dexamethasone arm.
The combination of pomalidomide, bortezomib and dexamethasone is associated with a response rate of 65% and 80% and patients refactorty to lenalidomide, even with previous exposure to a proteasome inhibitor.
With relapsed/refractory multiple myeloma previously exposed to lenalidomide, the combination of pomalidomide plus bortezomib and low‐dose dexamethasone (PVd) improved response and progression-free survival, results of the phase 3 OPTIMISMM trial.
The most common side effects reported include: fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infections, back pain, and pyrexia.
Can cause embryo-fetal toxicity and venous thromboembolism.
Dose modification is recommended for patients with renal impairment as the drug is primarily excreted through the kidneys.
It is recommended that patients with a serum creatinine of greater than 3 mg/dL avoid treatment with this agent.
A drug with REMS requirement.
The recommended dose and schedule for pomalidomide is 4 mg taken orally on days 1-21 of repeated 28-day cycles.
Cycles are repeated until disease progression.
Thromboprophylaxis should be considered because of the risk of thromboses.
Approved pomalidomide for the treatment of adults with AIDS-related Kaposi sarcoma that did not respond to highly active antiretroviral therapy and Kaposi sarcoma in adults who are HIV-negative.
Study 12-C-0047 clinical trial, in which 28 patients with refractory KS received pomalidomide 5 mg once daily on days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity occurred. Of note, all patients who are HIV-positive continued receiving highly active antiretroviral therapy.
Among the 18 HIV-positive patients, the ORR was 67% and the median duration of response was 12.5 months.
Among the 10 HIV-negative patients, these values were 80% and 10.5 months, respectively.