Medication Monitor



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  • March 19, 2019

    Roche announced FDA approval of atezolizumab in combination with carboplatin and etoposide (chemotherapy) for first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

    Atezolizumab is a monoclonal antibody designed to bind with the PD-L1 protein expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, the drug may enable the activation of T cells.

    Approval was based on results from a Phase III study showing that atezolizumab in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival =12.3 vs. 10.3 mo; hazard ratio [HR] = 0.70 [95% CI 0.54–0.91]; P = 0.0069) in the intention-to-treat population.

    The atezolizumab-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (PFS = 5.2 vs. 4.3 mo; HR = 0.77, 0.62–0.96; P = 0.017). Safety for the atezolizumab and chemotherapy combination appeared consistent with the known safety profile of atezolizumab.

    Atezolizumab is approved in combination with bevacizumab, paclitaxel, and carboplatin (chemotherapy) for first-line treatment of adults with metastatic nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations.

    It is also approved for treatment of adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations before receiving atezolizumab.

  • March 13, 2019

    Aerie Pharmaceuticals announced FDA approval of netarsudil and latanoprost ophthalmic solution 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

    The once-daily eyedrop is a fixed-dose combination of latanoprost, the most widely prescribed prostaglandin analog (PGA), and netarsudil, the active ingredient in netarsudil ophthalmic solution 0.02% (Rhopressa), a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork (the eye’s principal drainage pathway). The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension.

    Netarsudil works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway.

    Approval was based on data from two Phase III registration trials, in which the agent achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured timepoint.

    Treatment was associated with generally mild and tolerable ocular adverse events, with minimal systemic side effects. The most common ocular adverse event in controlled clinical studies was conjunctival hyperemia. Ninety percent of patients who experienced hyperemia reported it as mild, and 5% discontinued because of it.

    Other common ocular adverse effects were instillation-site pain, corneal verticillata, and conjunctival hemorrhage.

    Aerie plans to launch the new product in the United States in the second quarter of 2019.

  • March 13, 2019

    Regeneron and Sanofi announced FDA approval of dupilumab for patients aged 12 to 17 years with moderate to severe atopic dermatitis (eczema) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

    The agent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases.

    Dupixent has been studied in more than 7,000 patients aged 12 years and older in more than 30 clinical trials. Its safety profile in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis and consistent through 52 weeks.

    The most common adverse events were injection-site reactions; eye and eyelid inflammation, including redness, swelling; and itching; oropharyngeal pain; and cold sores in the mouth or on the lips.

    Dupixent comes in two doses (200 mg and 300 mg), each as a prefilled syringe. Dupixent is intended for S.C. injection and is given every other week following an initial loading dose. It can be given in a clinic or, for convenience, at home by self-administration after training by a health professional.

    Dupixent is also approved for treatment of adult patients with moderate to severe atopic dermatitis that is not well controlled with topical prescription drugs or who cannot use topical therapies; and for use with other asthma medications for maintenance treatment of moderate to severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines.

  • March 13, 2019

    FDA granted accelerated approval to atezolizumab plus chemotherapy (nab-paclitaxel [Abraxane]) for treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TBNC) whose tumors express PD-L1, as determined by an FDA-approved test.

    Accelerated approval was based on data from a Phase III study demonstrating that atezolizumab plus nab-paclitaxel significantly reduced the risk of disease worsening or death by 40% compared with nab-paclitaxel alone in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. 

    The most common adverse effects of atezolizumab plus nab-paclitaxel were low white blood cell count, tingling or numbness in the hands and feet, decreased neutrophil count, fatigue, low red blood cell count, low blood potassium levels, pneumonia, and increased AST levels.

  • March 13, 2019

    Pfizer announced FDA approval of trastuzumab-qyyp, a biosimilar to trastuzumab (Herceptin), for treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

    Approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between trastuzumab-qyyp and trastuzumab. This includes results from the REFLECTIONS B327-02 clinical comparative study recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between trastuzumab and the originator product in patients with first-line, HER2-overexpressing metastatic breast cancer.

    Trastuzumab is a monoclonal antibody biosimilar that targets HER2, a protein found on the surface of some cancer cells that can stimulate the cells to divide and grow. The agent locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.

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