Medication Monitor

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Generic Name (Trade Name—Company)
  • April 25, 2015

    FDA approved ramucirumab for use in combination with Folfiri (the combination drug irinotecan with fluorouracil [5FU] and folinic acid) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen.

    Ramucirumab is a recombinant human monoclonal IgG1 antibody that binds to the human vascular endothelial growth factor–receptor 2 (VEGF-R2), preventing the interaction of VEGF-R2 to its ligands.

    Approval was based on the results of a randomized, double-blind, multinational trial enrolling patients with mCRC who progressed during or within 6 months of discontinuation of bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy.

    The clinical trial accrued 1,072 patients who were randomly allocated (1:1) to receive Folfiri plus placebo or Folfiri plus ramucirumab (N = 536 per arm). Treatment cycles on both arms were repeated every 2 weeks, and ramucirumab was administered at a dose of 8 mg/kg by I.V. infusion every 2 weeks. Ramucirumab was continued until diseaseprogression or unacceptable toxicity.  

    The primary efficacy endpoint was overall survival (OS). Treatment assignment was stratified by geographic region (North America vs. Europe vs. other regions), KRAS status (wild-type vs. mutant) and time to progression for the beginning of first-line treatment (<6 months vs. greater than or equal to 6 months).  

    The median age of the study population was 62 years, 57% were men, and 99% had an ECOG performance status of 0 or 1. A statistically significant OS improvement was observed in patients receiving Folfiri plus ramucirumab compared with those receiving Folfiri plus placebo (HR 0.85 [95% CI 0.73–0.98], P =0.023, stratified log-rank test). Median OS was 13.3 and 11.7 months for patients on the Folfiri plus ramucirumab and Folfiri plus placebo arms, respectively. 

    PFS was also significantly improved in patients who received ramucirumab in combination with Folfiri (HR 0.79 [95% CI 0.70–0.90], P < 0.001). Median PFS was 5.7 and 4.5 months, respectively.    In general, the safety data were consistent with the known safety profile established in previously approved indications. However, thyroid dysfunction (hypothyroidism) was reported in 2.6% of patients based on thyroid monitoring in patients with mCRC.

    The recommended dose and schedule in patients receiving ramucirumab in combination with Folfiri after progression on a first-line bevacizumab containing regimen is 8 mg/kg administered every 2 weeks as a 60-minute I.V. infusion.  

  • April 29, 2016

    FDA has approved glycopyrrolate and formoterol fumarate inhalation aerosol for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. The agent is not indicated to treat asthma or for the relief of acute bronchospasm.

    The agent is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA).

    Approval was based on the Pinnacle trial program, which demonstrated that the product achieved statistically significant improvement in morning predose forced expiratory volume in 1 second (FEV1) at 24 weeks versus its mono-components and placebo.

    The most common adverse reactions were urinary tract infection and cough.

    The product is the first approved using AstraZeneca’s Co-Suspension Technology, which enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

  • March 8, 2016

    FDA approved coagulation Factor IX (recombinant), albumin fusion protein, under the trade name Idelvion, for use in children and adults with hemophilia B. Idelvion is the first coagulation factor–albumin fusion protein product to be approved and the second Factor IX fusion protein product approved in the United States that is modified to last longer in the blood.

    Idelvion is used to replace Factor IX, a naturally occurring clotting factor that is missing or defective in people with Hemophilia B (also called congenital Factor IX deficiency or Christmas disease). Idelvion is produced by recombinant DNA technology linking Factor IX to albumin, which accounts for the product lasting longer when given intravenously. It is is indicated for on-demand control and prevention of bleeding episodes, management of bleeding following surgery, and as a routine preventive measure to reduce the frequency of bleeding episodes. Idelvion potentially requires less-frequent injections than unmodified Factor IX when used for prevention.

    Safety and efficacy of Idelvion were evaluated in two multicenter studies that included 90 adult and pediatric patients with hemophilia B who were between age 1 year and 61 years. 

    Idelvion was demonstrated to be effective in controlling bleeding episodes and in managing perioperative bleeding. Its use as a prophylaxis led to a significant reduction in the rate of spontaneous bleeding episodes per year despite less-frequent infusions of Idelvion.

    No safety concerns were identified in the studies. Headache was the most common adverse effect observed.

  • November 30, 2018

    On November 16, FDA approved brentuximab vedotin injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

    PTCLs are rare, fast-growing non–Hodgkin's lymphomas that develop from T-cells. The T-cells often spread quickly throughout the body and are hard to treat.

    Brentuximab vedotinis a monoclonal antibody that binds to a CD30 protein found on some cancer cells. 

    The drug was previously approved to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic ALCL after failure of other treatment, and primary cutaneous ALCL or CD30-expressing mycosis fungoides after failure of other treatment.

    The new approval was based on a clinical trial of 452 patients with certain PTCLs who received either brentuximab vedotin plus chemotherapy or a standard chemotherapy (CHOP) as first-line treatment.

    The most common adverse effects of brentuximab vedotin plus chemotherapy included nerve damage (peripheral neuropathy), nausea and vomiting, diarrhea, low white blood cell counts, fatigue, mouth sores, constipation, hair loss, fever, and anemia.

    Health care providers are advised to monitor patients for infusion reactions, life-threatening allergic reactions, neuropathy, fever, GI complications and infections. Patients should also be monitored for tumor lysis syndrome, serious skin reactions, lung adverse effects, and liver damage.

    Women who are pregnant or breastfeeding should not take brentuximab vedotin because it may cause harm to a developing fetus or newborn baby.

    The prescribing information includes a boxed warning to advise health professionals and patients about the risk of a fatal or life-threatening infection of the brain (progressive multifocal leukoencephalopathy) in patients receiving the drug.

  • March 2, 2016

    FDA approved everolimus for the treatment of adult patients with progressive, well-differentiated (low- or intermediate-grade), nonfunctional (no current or prior history of carcinoid symptoms), neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced, or metastatic disease. 

    Everolimus was approved in 2009 for renal cell carcinoma, in 2010 for the prevention of renal transplant rejection, and in 2013 for the prevention of liver transplantation.  

    Approval for this new indication was based on demonstration of improvement in progression-free survival (PFS) in a multicenter, randomized (2:1), placebo-controlled trial of everolimus 10 mg orally once daily plus best supportive care (BSC), compared with placebo plus BSC.

    The clinical trial enrolled 302 patients with NET who showed evidence of disease progression within 6 months before randomization. The major efficacy outcome measure was PFS. Median PFS was 11 months and 3.9 months in the everolimus and placebo arms, respectively. 

    Overall response rates were 2% in the everolimus arm and 1% in the placebo arm. At the planned interim analysis, there was no statistically significant difference in overall survival between arms. 

    Safety data were evaluated in 300 patients who received at least one dose of investigational drug. The median exposure duration to everolimus was 9.3 months; 64% of patients were treated for 6 months or longer, and 39% were treated for 12 months or longer.

    Everolimus was discontinued for adverse reactions in 29% of patients, and dose reduction or delay was required in 70% of everolimus-treated patients. 

    Serious adverse reactions occurred in 42% of everolimus-treated patients and included three fatal events (cardiac failure, respiratory failure, and septic shock). 

    The most common adverse reactions (≥30%) were stomatitis, infections, diarrhea, peripheral edema, fatigue, and rash. The most common laboratory abnormalities (≥50%) were anemia, hypercholesterolemia, lymphopenia, elevated aspartate transaminase, and fasting hyperglycemia.

    The recommended dose and schedule for everolimus is 10 mg orally once daily.