Medication Monitor



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  • September 27, 2018

    FDA granted regular approval to duvelisib for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

    In addition, duvelisib received accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.

    The CLL and SLL indication is based on a randomized, multicenter, open-label trial comparing duvelisib with ofatumumab in patients with relapsed or refractory CLL or SLL. The trial randomized patients (1:1) to either duvelisib 25 mg orally twice daily or ofatumumab.

    Ofatumumab was administered intravenously at an initial dose of 300 mg, followed 1 week later by 2,000 mg once weekly for seven doses, then 2,000 mg once every 4 weeks for four additional doses.

    Among 196 patients receiving at least two prior therapies (95 randomized to duvelisib, 101 to ofatumumab), the estimated median progression-free survival, as assessed by an independent review committee, was 16.4 months in the duvelisib arm and 9.1 months in the ofatumumab arm (hazard ratio of 0.40; standard error 0.2). The overall response rate (ORR) was 78% and 39% for the duvelisib and ofatumumab arms, respectively (39% difference, standard error 6.5%).

    The FL indication is based on a single-arm multicenter trial of duvelisib enrolling 83 patients with FL who were refractory to rituximab and to either chemotherapy or radioimmunotherapy. The ORR was 42% (95% CI 31–54), with 41% of patients experiencing partial responses and one patient having a complete response.

    Of the 35 responding patients,15 (43%) maintained responses for at least 6 months, and 6 (17%) maintained responses for at least 12 months. Continued approval for the FL indication may be contingent on verification of clinical benefit demonstrated in a planned randomized trial.

    The prescribing information contains boxed warnings for fatal and/or serious infections, diarrhea or colitis, cutaneous reactions, and pneumonitis, and warnings for neutropenia and hepatotoxicity.

    Of 442 patients with hematologic malignancies treated with duvelisib at the approved dose, 65% had serious adverse reactions, with the most frequent being infection, diarrhea or colitis, and pneumonia.

    The most common adverse reactions (≥20%) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia. Adverse reactions resulted in permanent discontinuation of duvelisib in 35% of patients. Dose reduction occurred in 24%.

    The recommended duvelisib dose is 25 mg orally twice daily, taken continuously in 28-day treatment cycles.

  • September 26, 2018

    FDA approved moxetumomab pasudotox-tdfk injection for I.V. use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The agent is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

    HCL is a rare, slow-growing cancer of the blood in which the bone marrow makes too many lymphocytes. HCL is named after these extra B cells, which look “hairy” when viewed under a microscope. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells, and platelets are produced.

    Efficacy of the agent was studied in a single-arm, open-label clinical trial of 80 patients who had received prior treatment for HCL with at least two systemic therapies, including a purine nucleoside analog. The trial measured durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR. Thirty percent of patients in the trial achieved durable CR, and the overall response rate (number of patients with partial or complete response to therapy) was 75%.

    Common adverse effects include infusion-related reactions, edema, nausea, fatigue, headache, fever, constipation, anemia, and diarrhea.

    The prescribing information includes a boxed warning to advise health professionals and patients about the risk of developing capillary leak syndrome, a condition in which fluid and proteins leak out of tiny blood vessels into surrounding tissues. Symptoms of capillary leak syndrome include difficulty breathing, weight gain, hypotension, or swelling of arms, legs, and/or face.

    The boxed warning also notes the risk of hemolytic uremic syndrome, a condition caused by the abnormal destruction of red blood cells. Patients should be made aware of the importance of maintaining adequate fluid intake, and blood chemistry values should be monitored frequently.

    Other serious warnings include decreased renal function, infusion-related reactions, and electrolyte abnormalities. Women who are breastfeeding should not take the drug.

  • September 5, 2018

    Merck announced FDA approval of two new HIV-1 medications for adult patients with no prior antiretroviral treatment experience: a once-daily fixed-dose combination tablet of doravirine 100 mg, lamivudine (3TC) 300 mg, and tenofovir disoproxil fumarate (TDF) 300 mg, approved under the trade name Delstrigo; and doravirine 100 mg, a new nonnucleoside reverse transcriptase inhibitor that is administered in combination with other antiretroviral medicines and was approved under the trade name Pifeltro. 

    Both drugs are administered orally once daily with or without food.

    Approval was based on findings from two pivotal, randomized, multicenter, double-blind, active controlled Phase III trials, DRIVE-AHEAD and DRIVE-FORWARD.

    Delstrigo is contraindicated in patients with a previous hypersensitivity reaction to 3TC. 

    Delstrigo and Pifeltro are contraindicated when coadministered with drugs that are strong CYP450 3A enzyme inducers because significant decreases in doravirine plasma concentrations may occur and lessen their effectiveness.

    Immune reconstitution syndrome can occur, including autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment.

    Renal impairment, including acute renal failure and Fanconi syndrome, has been reported with use of TDF. Delstrigo should be avoided with concurrent or recent use of a nephrotoxic agent, as cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in patients with risk factors for renal dysfunction who appeared stable on TDF.

    Common adverse reactions in clinical trials included dizziness (7%), nausea (5%) and abnormal dreams (5%). 

    Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.

  • August 28, 2018

    Tetraphase Pharmaceuticals announced FDA approval of eravacycline for the treatment of complicated intra-abdominal infections (cIAI) in patients aged 18 years and older.

    In clinical trials, eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical noninferiority to two widely used comparators—ertapenem and meropenem.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of eravacycline and other antibacterial drugs, eravacycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    Eravacycline is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity reactions have been reported with use of the drug.

    The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion-site reactions, nausea, and vomiting. 

  • August 28, 2018

    FDA approved lanadelumab, the first monoclonal antibody approved in the United States to treat patients aged 12 years and older with types I and II hereditary angioedema (HAE).

    HAE is a rare and serious genetic disease that affects an estimated 1 in 50,000 men and women with low levels of and poorly functioning C1-INH proteins. This results in recurrent, unpredictable episodes of severe swelling in different areas of the body, including the stomach, limbs, face, and throat.

    Type I is the most common and accounts for 85% of cases. Symptoms of HAE typically begin in childhood and worsen following puberty. Some patients may have many attacks each month, while others will go months without an attack.

    FDA based its approval on data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 125 patients with HAE. Patients who received lanadelumab had clinically meaningful and statistically significant reductions in the rate of investigator-confirmed HAE attacks compared with placebo over a 6-month treatment period.

    The most common adverse reactions in clinical trials were injection-site reactions, upper respiratory infections, headache, rash, muscle pain, dizziness, and diarrhea.

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