Medication Monitor

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Generic Name (Trade Name—Company)
  • October 1, 2018

    FDA has approved dacomitinib, a kinase inhibitor for first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

    Safety and efficacy of dacomitinib were demonstrated in ARCHER 1050, a randomized, multicenter, multinational, open-label study in which 452 patients were randomized 1:1 to treatment with dacomitinib or with gefitinib. A statistically significant improvement was demonstrated in patients receiving dacomitinib compared with gefitinib.

    The most common adverse reactions were diarrhea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus.

    The most common serious adverse reactions reported were diarrhea and interstitial lung disease. The full prescribing information can be found here.

  • October 1, 2018

    FDA approved amikacin liposome inhalation suspension to treat lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC), in a limited population of patients with the disease who do not respond to conventional treatment. The drug is an inhaled treatment taken through a nebulizer.

    MAC is a type of nontuberculous mycobacteria (NTM) commonly found in water and soil. Symptoms of disease in patients with MAC include persistent cough, fatigue, weight loss, night sweats, and occasionally, shortness of breath and coughing up of blood.

    It is the first drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress under the 21st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need. Approval under the LPAD pathway may be supported by a streamlined clinical development program. These programs may involve smaller, shorter, or fewer clinical trials. As required for drugs approved under the LPAD pathway, the labeling includes certain statements to convey that the drug has been shown to be safe and effective only for use in a limited population.

    Approval was based on achieving three consecutive negative monthly sputum cultures by month six of treatment. FDA requires the sponsor to conduct an additional postmarketing study to describe the drug's clinical benefits.

    Safety and efficacy were demonstrated in a randomized, controlled clinical trial in which patients were assigned to one of two treatment groups: one group receiving amikacin plus a background multidrug antibacterial regimen, and the other group receiving a background multidrug antibacterial regimen alone.

    By the sixth month of treatment, 29% percent of patients treated with amikacin had no growth of mycobacteria in their sputum cultures for three consecutive months, compared with 9% of patients who were not treated with amikacin.

    The prescribing information includes a boxed warning about the increased risk of respiratory conditions. Other common adverse effects are difficulty speaking, cough, damaged hearing, upper airway irritation, musculoskeletal pain, fatigue, diarrhea, and nausea.

  • October 1, 2018

    FDA approved cemiplimab-rwlc injection for I.V. use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

    By blocking the PD-1 pathway, cemiplimab-rwlc may help the body’s immune system fight the cancer cells.

    Safety and efficacy of cemiplimab-rwlc was studied in two open-label clinical trials. Results showed that 47.2% percent of all patients treated with the agent had their tumors shrink or disappear. The majority of these patients had ongoing responses at the time of data analysis.

    Common adverse effects of cemiplimab-rwlc include fatigue, rash, and diarrhea. The agent must be dispensed with a patient Medication Guide that describes uses of the drug and its serious warnings.

    Serious adverse reactions include the risk of immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, and dermatologic and kidney problems. Patients should also be monitored for infusion-related reactions.  

    Because the agent can cause harm to a developing fetus, women should be advised of the potential risk to the fetus and to use effective contraception.


  • 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.