Medication Monitor

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  • August 28, 2018

    FDA has approved cenegermin, the first drug for treatment of neurotrophic keratitis, a rare disease affecting the cornea.

    Neurotrophic keratitis is a degenerative disease resulting from a loss of corneal sensation. The loss of corneal sensation impairs corneal health, causing progressive damage to the top layer of the cornea, including corneal thinning, ulceration, and perforation in severe cases. Prevalence of neurotrophic keratitis has been estimated to be fewer than 5 in 10,000 individuals.

    Safety and efficacy were studied in 151 patients with neurotrophic keratitis in two randomized, controlled, multicenter, double-masked studies lasting 2 weeks.

    Across both studies, complete corneal healing in 8 weeks was demonstrated in 70% of patients treated with cenegermin compared with 28% of patients treated without cenegermin.

    The most common adverse reactions in patients taking cenegermin are eye pain, ocular hyperemia (enlarged blood vessels in the white of the eyes), eye inflammation, and increased lacrimation (watery eyes).

  • August 21, 2018

    FDA granted accelerated approval to nivolumab for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.

    Approval was based on demonstration of a durable overall response rate (ORR) in a subgroup of patients from CheckMate-032, a multicenter, open-label trial in patients with metastatic solid tumors. This subgroup comprised 109 patients with metastatic SCLC, with disease progression after platinum-based therapy and at least one other prior line of therapy, regardless of tumor PD-L1 status.

    All patients received nivolumab 3 mg/kg by I.V. infusion over 60 minutes every 2 weeks.

    The ORR was 12%. Responses were durable for 6 months or longer in 77%, 12 months or longer in 62%, and 18 months or longer in 39% of the 13 responding patients. PD-L1 tumor status did not appear to be predictive of response.

    Safety data were evaluated in 245 patients with metastatic SCLC with disease progression following platinum-based chemotherapy and received at least one dose of nivolumab at a dose of 3 mg/kg every 2 weeks.

    The most common (≥20%) adverse reactions were fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation, and cough. Nivolumab was discontinued for adverse reactions in 10% of patients, and 25% of patients had at least one dose withheld for an adverse reaction.

    Serious adverse reactions occurred in 45% of patients. The most frequent (≥2%) serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.

    The recommended dose and schedule of nivolumab for this indication is 240 mg every 2 weeks over 30 min.

  • August 21, 2018

    FDA approved pembrolizumab in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

    Approval was based on the results of KEYNOTE-189, a randomized, multicenter, double-blind, active controlled study enrolling 616 patients receiving first-line treatment for metastatic NSqNSCLC. The trial demonstrated a statistically significant improvement in overall survival for patients randomized to pembrolizumab and chemotherapy in a prespecified interim analysis. 

    The most common adverse reactions were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

    The recommended pembrolizumab dose and schedule for this indication is 200 mg as an I.V. infusion over 30 minutes every 3 weeks.

  • August 21, 2018

    Vertex Pharmaceuticals announced FDA approval of ivacaftor to include use in children with cystic fibrosis (CF) aged 12 months to younger than 24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor, based on clinical and/or in vitro assay data.

    FDA approval for this indication was based on data from the ongoing Phase III open-label safety study (ARRIVAL) of 25 children with CF aged 12 months to younger than 24 months who have 1 of 10 mutations in the CFTR gene.

    The study demonstrated a safety profile consistent with that observed in previous Phase III studies of older children and adults; most adverse events were mild or moderate in severity, and no patient discontinued because of adverse events. Two patients had elevated liver enzymes greater than eight times the upper limit of normal but continued to receive ivacaftor after a dose interruption.

    The most common adverse events (≥30%) were cough (74%), pyrexia (37%), elevated aspartate aminotransferase (37%), elevated alanine aminotransferase (32%), and runny nose (32%). Four serious adverse events were observed in two patients.

    Mean baseline sweat chloride for the children in this study was 104.1 mmol/L (n = 14). Following 24 weeks of treatment with ivacaftor, the mean sweat chloride level was 33.8 mmol/L (n = 14). In the 10 participants with paired sweat chloride samples at baseline and week 24, there was a mean absolute change of -73.5 mmol/L.

    Ivacaftor was previously approved for treatment of CF in patients aged 2 years and older who have 1 of 38 ivacaftor-responsive mutations in the CFTR gene, based on clinical and/or in vitro assay data.

  • August 20, 2018

    Sun Pharma announced FDA approval of cyclosporine ophthalmic solution 0.09% to increase tear production in patients with keratoconjunctivitis sicca (dry eye).     

    Approval was based on a Phase III trail showing that after 12 weeks of treatment, cyclosporine ophthalmic solution 0.09% showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production), compared with vehicle. Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment.

    The solution is dosed twice daily and will be available as a single-use vial.