Medication Monitor



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  • July 19, 2018

    FDA approved ribociclib in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

    FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

    This is the first approval that FDA has granted as part of two new pilot programs announced earlier this year that collectively aim to make the development and review of cancer drugs more efficient, while improving FDA’s rigorous standard for evaluating efficacy and safety. With this real-time review, FDA was able to start evaluating the clinical data as soon as the trial results become available, enabling FDA to be ready to approve the new indication upon filing of a formal application with the agency.

    Currently the two pilot programs are being used for supplemental applications for already approved cancer drugs and could later be expanded to original drugs and biologics.

    Ribociclib was first approved in March 2017 for use with an AI to treat HR-positive, HER2-negative breast cancer in postmenopausal women whose cancer is advanced or has spread to other parts of the body.

  • July 10, 2018

    FDA approved incobotulinumtoxinA to treat chronic sialorrhea, or excessive drooling, in adult patients. It is the first and only neurotoxin with this approved indication in the United States.

    Sialorrhea is a common symptom among patients who have neurological disorders such as Parkinson disease, amyotrophic lateral sclerosis, or cerebral palsy or who have had a stroke. The condition can occur from difficulty retaining saliva inside the mouth, from issues with swallowing, and from problems controlling facial muscles.

    Approval for this indication was based on a Phase III, randomized, double-blind, placebo-controlled, multicenter trial involving 184 patients in which both coprimary endpoints were successfully achieved. Study participants received placebo (n = 36), incobotulinumtoxinA 75 U (n = 74), or incobotulinumtoxinA 100 U (n = 74). Overall frequency of adverse events was similar between placebo and treatment groups, with no new or unexpected adverse events reported. 

    This is the fourth neurological indication for the neurotoxin, which was first approved by FDA in 2010 to treat cervical dystonia and blepharospasm (in patients previously treated with onabotulinumtoxinA) in adult patients and later in 2015 for upper limb spasticity in adult patients.

  • July 9, 2018

    FDA approved encorafenib and binimetinib in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

    Approval was based on a randomized, active-controlled, open-label, multicenter trial in 577 patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. Patients were randomized (1:1:1) to receive binimetinib 45 mg twice daily plus encorafenib 450 mg once daily, encorafenib 300 mg once daily, or vemurafenib 960 mg twice daily. Treatment continued until disease progression or unacceptable toxicity.

    The major efficacy measure was progression-free survival (PFS) using RECIST 1.1 response criteria and assessed by blinded independent central review. The median PFS was 14.9 months for patients receiving binimetinib plus encorafenib and 7.3 months for the vemurafenib monotherapy arm (hazard ratio 0.54 [95% CI 0.41–0.71], P < 0.0001). Overall response rates assessed by central review were 63% and 40%, respectively. Median response duration was 16.6 months vs. 12.3 months, respectively.

    The most common (≥25%) adverse reactions in patients receiving the combination were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. Discontinuation of therapy due to adverse reactions occurred in 5% of patients receiving the combination; the most common reasons were hemorrhage and headache.

    FDA also granted approval of the THxID BRAF Kit (bioMérieux) as a companion diagnostic for these therapeutics.

    The recommended doses are binimetinib 45 mg orally twice daily and encorafenib 450 mg orally once daily.

  • June 26, 2018

    Shire announced FDA approval of an expanded indication for C1 esterase inhibitor (human) to prevent angioedema attacks in children aged 6 years and older with hereditary angioedema (HAE). The product has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE.

    HAE is a rare, genetic disorder estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide. The condition results in recurring attacks of edema in various parts of the body, including the abdomen, face, feet, genitals, hands, and throat. The attacks can be debilitating and painful, with those that obstruct the airways potentially life threatening because of the risk of asphyxiation.

    The agent is contraindicated in patients who have had life-threatening, immediate hypersensitivity reactions, including anaphylaxis, after using it.

    Health professionals are urged to consider treatment methods carefully because hypersensitivity reactions may have symptoms similar to HAE attacks. If an acute severe hypersensitivity reaction occurs, infusion of the product should be discontinued and epinephrine administered.

  • June 26, 2018

    FDA approved desmopressin acetate as the first sublingual tablet for treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. The formulation of the sublingual tablet and sex-specific dosing was demonstrated to be effective in reducing nighttime trips to the bathroom in adults aged 18 years and older.

    Nocturnal polyuria, a disease of the kidneys, is the most common underlying cause of nocturia, which can affect adults at every age. It occurs when a person has insufficient nocturnal vasopressin, causing an overproduction of urine in the kidneys at night. Unlike treatments that target the bladder or prostate, desmopressin acetate acts on receptors in the kidney to absorb more fluid and produce less urine during the night while patients sleep.

    The product was approved with a boxed warning because it can cause hyponatremia. Severe hyponatremia can be life threatening, leading to seizures, coma, respiratory arrest, or death.

    Desmopressin acetate will be available in the second half of 2018.

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