Medication Monitor



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  • June 14, 2018

    FDA granted accelerated approval of pembrolizumab to treat patients with cancer whose unresectable or metastatic solid tumors have a specific genetic feature (biomarker), referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

    This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.

    MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial, and gastrointestinal cancers but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland, and other places. Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.

    Pembrolizumab works by targeting the PD-1/PD-L1 cellular pathway. By blocking this pathway, the drug may help the body’s immune system fight the cancer cells. FDA previously approved the agent to treat certain patients with metastatic melanoma, metastatic non–small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

    Safety and efficacy of pembrolizumab for this indication were studied in patients with MSI-H or dMMR solid tumors who were enrolled in one of five uncontrolled, single-arm clinical trials. In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumor samples after treatment began. 

    A total of 15 cancer types were identified among 149 patients enrolled across these five clinical trials. The most common cancers were colorectal, endometrial, and other gastrointestinal cancers. Approval for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received pembrolizumab in the trials, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for 6 months or more.

    Common adverse effects  include fatigue, pruritus, diarrhea, decreased appetite, rash, fever, cough, difficulty breathing, musculoskeletal pain, constipation, and nausea.

    Pembrolizumab can cause serious conditions, known as immune-mediated adverse effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies), and kidneys (nephritis). Complications or death related to allogeneic hematopoietic stem cell transplantation after using pembrolizumab has occurred.

    Patients who experience severe or life-threatening infusion-related reactions should stop taking pembrolizumab. Women who are pregnant or breastfeeding should not take pembrolizumab because it may cause harm to a developing fetus or newborn baby.

    Safety and effectiveness of the agent in pediatric patients with MSI-H central nervous system cancers have not been established.

  • June 8, 2018

    Genentech announced FDA approval of rituximab to treat adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

    Rituximab is the first biologic therapy approved by FDA for PV and the first major advancement in treatment of the disease in more than 60 years. The agent is now approved to treat four autoimmune diseases.

    Approval was based on data from the Ritux 3 trial, a randomized, controlled trial conducted in France that used Roche-manufactured, European Union (EU)–approved rituximab product as the clinical trial material. The study compared the Ritux 3 regimen (EU-approved rituximab product plus short-term corticosteroids [CS]) to CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus. The primary endpoint of the study was complete remission at month 24 without use of steroids for 2 or more months.

    Results of the study showed that 90% of patients with PV treated with the Ritux 3 regimen met the endpoint, compared with 28% of patients with PV who were treated with CS alone. These results supported rituximab's efficacy in treating patients with moderate to severe PV, while tapering off CS therapy.

    Rituxan can cause serious adverse effects that can lead to death, including severe skin and mouth reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.

    Common adverse effects include infusion reactions, infections (with fever and chills), body aches, tiredness, and nausea.

  • June 8, 2018

    FDA approved methoxy polyethylene glycol-epoetin beta for the treatment of pediatric patients aged 5 to 17 years on hemodialysis who are converting from another erythropoietin-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.

    Approval was based on data from an open-label, multiple dose, multicenter, dose-finding trial in 64 pediatric patients (aged 5–17 y) with chronic kidney disease (CKD) on hemodialysis and had stable hemoglobin (Hb) levels while previously receiving another ESA (epoetin alfa/beta or darbepoetin alfa). Patients were administered methoxy polyethylene glycol-epoetin beta intravenously once every 4 weeks for 20 weeks. After the first administration, dosage adjustments were permitted to maintain target Hb levels.

    Efficacy was based on maintaining Hb levels within target levels in the above clinical trial, and also from extrapolation from trials the agent in adult patients with CKD. The safety findings observed in pediatric patients were consistent with those previously reported in adults.

    For conversion from another ESA, Mircera is dosed intravenously once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion. Full prescribing information is available at Mircera PI.

  • June 2, 2018

    FDA approved estradiol vaginal inserts for treatment of moderate to severe vaginal pain associated with sexual activity, a symptom of vulvar and vaginal atrophy (VVA) due to menopause. It is the only product in its therapeutic class to offer a 4-mcg and 10-mcg dose, the 4 mcg representing the lowest approved dose of vaginal estradiol available.

    VVA is a component of genitourinary syndrome of menopause, which may include but is not limited to genital symptoms of dryness, burning, and irritation; sexual symptoms such as decreased lubrication, discomfort, and pain; and urinary symptoms such as urgency, dysuria, and recurrent urinary tract infections. VVA is a chronic, progressive condition that leads to distressing symptoms and can worsen if not treated.

    The product's mechanism of action is re-estrogenization of the tissue in and around the vagina. The formulation ensures that it dissolves completely without mess, so patients can use it any time of day by placing the softgel capsule in the lower part of the vagina to treat the vulva and vagina. 

    The inserts are administered daily for 2 weeks, followed by only twice-a-week dosing.

    The most common adverse reaction (incidence ≥3%) and greater than placebo was headache. No clinically significant differences in adverse events were observed between treatment and placebo groups.

  • May 31, 2018

    FDA expanded the approval of tofacitinib to include adults with moderately to severely active ulcerative colitis.

    It is the first oral medication approved for chronic use in this indication. Other FDA-approved treatments for chronic treatment of this condition must be administered through an I.V. infusion or S.C. injection.

    Efficacy of tofacitinib for treatment of moderately to severely active ulcerative colitis was demonstrated in three controlled clinical trials. This included two 8-week placebo-controlled trials that demonstrated that 10 mg of tofacitinib given twice daily induces remission in 17% to 18% of patients by week eight.

    In a placebo-controlled trial among patients who achieved a clinical response by week eight, a 5- or 10-mg dose of tofacitinib given twice daily was effective in inducing remission by week 52 in 34% and 41% of patients, respectively. Among patients who achieved remission after 8 weeks of treatment, 35% and 47% achieved sustained corticosteroid-free remission when treated with 5 mg and 10 mg, respectively.

    Safety of chronic use of tofacitinib for ulcerative colitis was studied in the 52-week placebo-controlled trial. Additional supportive safety information was collected from patients who received treatment in an open-label, long-term study.

    The most common adverse events associated with treatment for ulcerative colitis were diarrhea, elevated cholesterol levels, headache, increased blood creatine phosphokinase, common cold, rash, and upper respiratory tract infection.

    Less common serious adverse events included malignancy and serious infections such as opportunistic infections. Tofacitinib has a boxed warning for serious infections and malignancy. Patients treated with tofacitinib are at increased risk for developing serious infections that may lead to hospitalization or death. Lymphoma and other malignancies have been observed in patients treated with tofacitinib.

    Use of tofacitinib in combination with biological therapies for ulcerative colitis or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

    The agent was previously approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.

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