Medication Monitor

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

    FDA approved a new indication for the antiepileptic drug (AED) perampanel hydrate as adjunctive therapy for primary generalized tonic–clonic (PGTC) seizures in patients with epilepsy 12 years of age and older.  

    Perampanel is a first-in-class, highly selective AMPA receptor antagonist first approved in the United States as adjunctive therapy for partial-onset seizures with or without secondarily generalized seizures in patients aged 12 years and older in 2012.  

    The new indication for PGTC was based on results of a Phase 3 study in 164 patients aged 12 years and older with PGTC seizures despite treatment with one to three AEDs. Patients received perampanel oral tablets, once daily, up to 8 mg/d in the titration period and 8 mg/d during the maintenance period.

    The study showed a statistically significant reduction in PGTC seizure frequency with perampanel compared with placebo (change, –76.5% vs –38.4%; P < .0001).

    In addition, significantly more children responded to perampanel than placebo (64.2% vs 39.5%; P = .0019). Roughly 31% of patients treated with perampanel were free of PGTC seizures, compared with 12% of those treated with placebo during the 13-week maintenance period.

    The most common adverse events associated with perampanel are dizziness, fatigue, headache, somnolence, and irritability.

  • December 22, 2015

    FDA expanded the approval of pembrolizumab for the initial treatment of patients with unresectable or metastatic melanoma.

    In 2014 pembrolizumab received accelerated approval based on a clinically meaningful, durable objective response rate in patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Two new clinical trials verified the clinical benefit of the drug.  

    The recommended dose and schedule for pembrolizumab is 2 mg/kg Q3W administered as an I.V. infusion every 3 weeks until disease progression or unacceptable toxicity.

  • February 10, 2015

    FDA has expanded the approved use for ranibizumab injection 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).

    In 2008, 33% of adults with diabetes aged 40 years or older had some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break.

    The drug is administered by a physician as an injection into the eye once a month. It is intended to be used along with appropriate interventions to control blood glucose levels, blood pressure, and cholesterol.

    The drug’s safety and efficacy to treat DR with DME were established in two clinical studies involving 759 participants who were treated and followed for 3 years. In the two studies, participants being treated with ranibizumab showed significant improvement in the severity of their DR at 2 years compared with patients who did not receive an injection.

    The most common adverse effects include bleeding of the conjunctiva, eye pain, floaters, and increased pressure inside the eye. Serious adverse effects include infection within the eyeball and retinal detachments.

    FDA granted ranibizumab for DR with DME breakthrough therapy designation and also reviewed the new use under the agency’s priority review program, which provides for an expedited review of drugs that demonstrate the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

    FDA previously approved ranibizumab to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula, resulting in blurred vision. Ranibizumab also is approved to treat neovascular age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula.

  • February 2, 2015

    FDA has expanded the approved use of ibrutinib for patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.

    A type of non-Hodgkin lymphoma, WM usually gets worse slowly over time and causes abnormal blood cells, B lymphocytes (B cells), to grow within the bone marrow, lymph nodes, liver, and spleen. In WM, abnormal B cells also overproduce immunoglobulin M or IgM (macroglobulin) that may lead to excess bleeding, vision problems, and nervous system problems.

    Ibrutinib works by blocking the enzyme that allows the abnormal B cells in WM to grow and divide.

    FDA initially granted ibrutinib accelerated approval in November 2013 for use in patients with mantle cell lymphoma who received one prior therapy. In February 2014, FDA granted accelerated approval to ibrutinib for use in patients with previously treated chronic lymphocytic leukemia (CLL) and then, in July 2014, expanded its use to include treatment of CLL patients who carry a deletion in chromosome 17.

    Approval of ibrutinib for WM was based on a clinical study of 63 previously treated participants who received a daily 420-mg, orally administered dose of the medication until disease progression or until adverse effects became intolerable. Results showed 62% of participants had their cancer shrink after treatment (overall response rate). At the time of the study, duration of response ranged from 2.8 months to approximately 18.8 months.

    The most common adverse effects associated with the drug are low blood platelet counts, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash.

    Health professionals should inform patients of the risk of hemorrhage, infections, abnormal heartbeat, development of new cancers, metabolic disturbances following treatment, and embryo-fetal toxicity associated with its use.

    FDA granted ibrutinib for WM breakthrough therapy designation, priority review, and orphan product designation because the company demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; has potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.

    The product’s new use is being approved more than 2 months ahead of its prescription drug user fee goal date of April 17, 2015, the date FDA was scheduled to complete review of the drug application.

  • October 14, 2015

    FDA has expanded the approved use of nivolumab to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy.

    The most common type of lung cancer, NSCLC is further divided into two main types named for the kinds of cells found in the cancer: squamous cell and nonsquamous cell (which includes adenocarcinoma). Nivolumab 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, nivolumab may help the body’s immune system fight the cancer cells.

    Earlier this year, FDA approved nivolumab to treat patients with advanced squamous NSCLC whose disease progressed during or after platinum-based chemotherapy.

    Safety and effectiveness of nivolumab for this use were demonstrated in an international, open-label, randomized study of 582 participants with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy. Participants were treated with nivolumab or docetaxel. The primary endpoint was overall survival, and the secondary endpoint was objective response rate (percentage of patients who experienced complete or partial shrinkage of their tumors).

    Those treated with nivolumab lived an average of 12.2 months compared with 9.4 months in those treated with docetaxel. In addition, 19% of those treated with nivolumab experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared with 12% among those taking docetaxel, which lasted an average of 6 months.

    While patients who received nivolumab lived longer than those who received docetaxel across the study, an evaluation of samples from a subgroup of patients’ tumors suggests that the level of PD-L1 expression in NSCLC tumors may help identify patients who are more likely to live longer as a result of treatment with nivolumab. Therefore, FDA also approved the PD-L1 IHC 28-8 pharmDx test (marketed by Dako North America Inc.) to detect PD-L1 protein expression levels and help physicians determine which patients may benefit most from treatment with nivolumab.

    Nivolumab's most common adverse effects are fatigue, musculoskeletal pain, decreased appetite, cough and constipation. Nivolumab also may cause serious adverse effects that result from the drug's immune system effect. These severe immune-mediated adverse effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands, and the brain.  

    FDA granted nivolumab breakthrough therapy designation for this indication on the basis of preliminary clinical evidence that suggested nivolumab may offer a substantial improvement over available therapies. It 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. Nivolumab's approval occurred approximately 3 months ahead of the prescription drug user fee goal date of January 2, 2016, the date the agency was scheduled to complete its review of the application.

    Another drug, pembrolizumab (Keytruda—Merck), also targets the PD-1/PD-L1 pathway and was granted accelerated approval last week for treating NSCLC specifically for patients whose tumors expressed PD-L1.