Medication Monitor



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  • October 30, 2015

    FDA approved an expanded use of ipilimumab for adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.   

    Approval was based on improvement in recurrence-free survival (RFS) in a randomized (1:1), double-blind, placebo-controlled trial in 951 patients with resected Stage IIIA (lymph node > 1 mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma.    

    The primary efficacy endpoint was RFS determined by an independent review committee. The median RFS was 26 and 17 months in the ipilimumab (n = 475) and placebo (n = 476) arms, respectively (hazard ratio [HR] 0.75 [95% CI 0.64–0.90], P <0.002, stratified log-rank test).    Safety data were evaluated in 945 patients (median age 51 y; 62% male), who received ipilimumab 10 mg/kg (n = 471) or placebo (n = 474) administered as an I.V. infusion for four doses every 3 weeks, followed by 10 mg/kg every 12 weeks beginning at week 24 up to a maximum of 3 years. Ipilimumab-treated patients received a median of four doses (range: 1–16), and 36% of patients received ipilimumab for longer than 6 months. Ipilimumab was discontinued for adverse reactions in 52% of patients.  

    The most common adverse reactions included rash, pruritus, diarrhea, nausea, colitis, vomiting, weight loss, fatigue, pyrexia, headache, decreased appetite, and insomnia.    

    Grades 3–5 immune-mediated adverse reactions, occurring in 41% of ipilimumab-treated patients, included enterocolitis (16%), hepatitis (11%), endocrinopathy (8%), dermatitis (4%), and neuropathy (1.7%). The five treatment-related deaths were due to immune-mediated adverse reactions of enterocolitis (3), Guillain-Barré syndrome (1), and myocarditis (1).  

    Patients should be assessed for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries, including liver function tests, adrenocorticotropic hormone level, and thyroid function tests, at baseline and before each dose.  

    The recommended dose and schedule for ipilimumab for adjuvant treatment of melanoma is 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. If toxicity occurs, doses are omitted, not delayed.

  • August 22, 2012

    Nephron Pharmaceuticals announced the launch of racepinephrine inhalation aerosol for temporary relief of bronchial asthma in patients 4 years and older. This OTC product is an alternative to the discontinued epinephrine inhalation aerosol (Primatene Mist Inhaler) which was removed from the market in December 2011 because of its CFC propellant.

    The product will be available in a starter kit that includes 10 vials and the EZ Breathe Atomizer. A refill package including 30 vials will be marketed as well. The EZ Breathe Atomizer is an OTC device that sprays liquid medication in aerosol form into the air for a patient to inhale.

  • October 14, 2015

    FDA granted accelerated approval for pembrolizumab to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express the PD-L1 protein. Pembrolizumab is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test (marketed by Dako North America Inc.), the first test designed to detect PD-L1 expression in NSCLC tumors.

    Pembrolizumab targets the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, pembrolizumab may help the body’s immune system fight the cancer cells. In 2014, pembrolizumab was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Another drug, nivolumab (Opdiva—Bristol-Meyers Squibb), also targets the PD-1/PD-L1 pathway and was approved to treat squamous NSCLC in 2015.

    Safety of pembrolizumab was studied in 550 patients with advanced NSCLC. Its most common adverse effects included fatigue, decreased appetite, shortness of breath or impaired breathing, and cough. Pembrolizumab  also has the potential to cause severe adverse effects that result from the immune system effect of the drug (immune-mediated adverse effects).

    Effectiveness of pembrolizumab for this use was demonstrated in a subgroup of 61 patients enrolled within a larger multicenter, open-label, multipart study. The subgroup consisted of patients with advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR). This subgroup also had PD-L1 positive tumors, as determined by the results of the 22C3 pharmDx diagnostic test.

    Study participants received pembrolizumab 10 mg/kg every 2 or 3 weeks. The major outcome measure was overall response rate (percentage of patients who experienced complete and partial shrinkage of their tumors). Tumors shrank in 41% of patients treated with pembrolizumab, and the effect lasted between 2.1 and 9.1 months.                                                                                                         

    In the 550 study participants with advanced NSCLC, severe immune-mediated adverse effects occurred involving the lungs, colon, and hormone-producing glands. Other uncommon immune-mediated adverse effects were rash and inflammation of blood vessels.

    Women who are pregnant or breastfeeding should not take pembrolizumab because it may cause harm to a developing fetus or newborn baby. Across clinical studies, a disorder in which the body's immune system attacks part of the peripheral nervous system (Guillain-Barre Syndrome) also occurred.

    FDA granted pembrolizumab breakthrough therapy designation for this indication because Merck demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. The drug also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

    Pembrolizumab was approved under the agency’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease on the basis of clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. An improvement in survival or disease-related symptoms in patients being treated with pembrolizumab has not yet been established.

  • August 20, 2015

    FDA has approved the use of extended-release oxycodone for long-term pain management in children aged 11 to 16 years old. The opioid is intended for pediatric patients whose pain has not responded to alternative treatments.

    Approval for the new indication was based on manufacturer-conducted studies on the safety of extended-release oxycodone and its pharmacokinetic profile in pediatric patients, according to FDA. The painkiller can only be prescribed to children who already tolerate at least 20 mg/d of oxycodone or its equivalent.

    Extended-release oxycodone was reformulated in 2010 to make the drug more difficult to abuse.

     

     

  • November 18, 2015

    FDA has approved antihemophilic factor (recombinant), polyethylene glycol (PEGylated), for use in adults and adolescents aged 12 years and older who have hemophilia A. The new therapy has been approved under the trade name Adynovate.

    Adynovate is modified to last longer in the blood and potentially require less-frequent injections than unmodified antihemophilic factor when used to reduce the frequency of bleeding.

    Adynovate is approved for on-demand treatment and control of bleeding episodes and to reduce the frequency of bleeding episodes in patients with hemophilia A. Adynovate consists of the full-length coagulation Factor VIII molecule (historically known as antihemophilic factor) linked to other molecules, known as polyethylene glycol (PEGylated). This link makes the product last longer in the patient’s blood.

    Safety and efficacy of adynovate were evaluated in a clinical trial of 137 adults and adolescents aged 12 years and older, which compared the recommended routine prophylactic treatment regimen to on-demand therapy. The trial demonstrated that Adynovate was effective in reducing the number of bleeding episodes during routine care. In addition, Adynovate was effective in treating and controlling bleeding episodes. No safety concerns were identified during the trial.

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