Medication Monitor



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  • June 12, 2019

    Regeneron announced FDA approval of aflibercept injection to treat all stages of diabetic retinopathy (DR) and thereby reduce the risk of blindness.

    The vascular endothelial growth factor (VEGF) inhibitor blocks the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis. 

    The agent was approved with two dosing options for DR: every 8 weeks following five initial monthly injections, or every 4 weeks.

    Approval of aflibercept as a treatment for DR was based on 6-month and 1-year results from PANORAMA, a randomized, multicenter, controlled Phase III trial that enrolled 402 patients. The trial was designed to investigate whether aflibercept improved moderately severe to severe NPDR without diabetic macular edema (DME), compared with a placebo injection. 

    The most common adverse reactions (≥5%) were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

     

  • June 12, 2019

    On May 10, 2019, FDA approved ramucirumab as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of 400 ng/mL or greater and have been previously treated with sorafenib.

    Approval was based on REACH‑2, a multinational, randomized, double-blind, placebo-controlled, multicenter study in 292 patients with advanced HCC with AFP of 400 ng/mL or greater who had disease progression on or after sorafenib or who were intolerant.

    The trial’s primary endpoint was overall survival (OS). The estimated median OS was 8.5 months for patients receiving ramucirumab and 7.3 months for those receiving placebo.

    The most common adverse reactions observed in patients with HCC receiving single-agent ramucirumab (≥15% and ≥2% higher incidence than placebo) were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities (≥30% and a ≥2% higher incidence than placebo) were hypoalbuminemia, hyponatremia, and thrombocytopenia.

    The recommended ramucirumab dosage is 8 mg/kg administered intravenously every 2 weeks.

  • June 11, 2019

    FDA approved a new indication for ivosidenib, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to treat adults with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Patients must be aged 75 years or older and have comorbidities that preclude use of intensive induction chemotherapy.

    The agent received initial FDA approval in July 2018 for adult patients with relapsed or refractory (R/R) AML and an IDH1 mutation.

  • June 5, 2019

    FDA approved ado-trastuzumab emtansine for adjuvant treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment.

    FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, leading to an approval 12 weeks after completing the submission. Ado-trastuzumab emtansine is the first Genentech medicine approved under the RTOR pilot program. Ado-trastuzumab emtansine was also granted breakthrough therapy designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

    Approval was based on results of the Phase III KATHERINE study showing ado-trastuzumab emtansine significantly reduced the risk of invasive breast cancer recurrence or death from any cause. At 3 years, 88.3% of people treated with ado-trastuzumab emtansine did not have their breast cancer return, compared with 77.0% treated with trastuzumab. People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.

    The most common adverse effects (>25%) with ado-trastuzumab emtansine were fatigue; nausea; increased blood levels of liver enzymes; musculoskeletal pain; bleeding; decreased platelet count; headache; numbness, tingling, or pain in the hands or feet; and joint pain.

    The goal in treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.

  • May 30, 2019

    FDA approved dapagliflozin, saxagliptin, and metformin hydrochloride extended-release tablets under the trade name Qternmet XR as a once-daily, oral medicine adjunct treatment to diet and exercise to improve glycaemic control in adults with type 2 diabetes (T2D).

    Approval was based on two Phase III trials that evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks in patients with inadequately controlled T2D. The safety results of the individual medicines in these trials were consistent with their known profile.

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