Medication Monitor



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  • June 27, 2019

    FDA approved dupilumab, given by injection, as the first treatment for adults with nasal polyps accompanied by inadequately controlled chronic rhinosinusitis. 

    Efficacy and safety of dupilumab were established in two studies with 724 patients, aged 18 years and older, with chronic rhinosinusitis with nasal polyps who were symptomatic despite taking I.N. corticosteroids. Patients who received dupilumab had statistically significant reductions in their nasal polyp size and nasal congestion compared with the placebo group. Patients taking dupilumab also reported an increased ability to smell and required less nasal polyp surgery and oral steroids.

    The agent may cause serious allergic reactions and eye problems, such as conjunctivitis and keratitis. If patients experience new or worsening eye symptoms, such as redness, itching, pain, or visual changes, they should consult their health professional. The most common adverse effects reported include injection site reactions as well as eye and eyelid inflammation, which included redness, swelling, and itching. Patients receiving dupilumab should avoid receiving live vaccines.

    Dupilumab was originally approved in 2017 for patients aged 12 years and older with eczema that is not controlled adequately by topical therapies or when those therapies are not advisable. In 2018, the agent was approved as add-on maintenance treatment for patients aged 12 years and older with moderate to severe eosinophilic asthma or with oral corticosteroid-dependent asthma.

  • June 25, 2019

    FDA expanded the indication of tezacaftor/ivacaftor tablets for treatment of pediatric patients aged 6 years and older with cystic fibrosis who have certain genetic mutations. Last year, FDA approved tezacaftor/ivacaftor to treat patients aged 12 and older who had the same specific genetic mutations.

    Tezacaftor/ivacaftor is used to treat patients who have two copies of the most common type of mutation—the F508del mutation—or who have at least one of the mutations in the CFTR gene that is responsive to the active ingredients, based on in vitro data and/or clinical evidence. Patients with cystic fibrosis and their caregivers should speak with a health professional and have tests performed to understand which gene mutations patients have and whether tezacaftor/ivacaftor is likely to work for them.

    Efficacy for patients with cystic fibrosis aged 12 years and older was evaluated in three Phase III, double-blind, placebo-controlled trials that demonstrated improvements in lung function and other key measures of the disease, including a reduction in exacerbations. Efficacy in patients aged 6 to 12 was extrapolated from patients aged 12 years and older, with additional support from data in patients aged 6 to 12 years.

    Safety of the agent to treat patients aged 6 years to younger than 12 years was supported by data from a study that included a 24-week, open-label treatment period with 70 participants.

    The medication should always be taken with food that contains fat and never in combination with certain antibiotics, seizure medicines, St. John’s wort, or food containing grapefruit or Seville oranges, as indicated on the label. The prescribing information includes warnings for elevated liver enzymes, for those who use inducers for the CYP3A liver enzyme, and for the risk of cataracts in pediatric patients.

    The most common adverse effects include headache, nausea, sinus congestion, and dizziness.

    Safety and efficacy in patients with cystic fibrosis who are younger than 6 years old have not been studied.

  • June 25, 2019

    FDA approved pembrolizumab for first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

    Pembrolizumab was approved for use in combination with platinum and fluorouracil for all patients and as a single agent for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA‑approved test. 

    FDA also expanded the intended use for the PD-L1 IHC 22C3 pharmDx kit to include use as a companion diagnostic device for selecting patients with HNSCC for treatment with pembrolizumab as a single agent.

    Approval was based on KEYNOTE-048, a randomized, multicenter, three-arm, open‑label, active‑controlled trial conducted in 882 patients with metastatic HNSCC who had not previously received systemic therapy for metastatic disease or with recurrent disease who were considered incurable by local therapies.

    The trial demonstrated a statistically significant improvement in overall survival in the overall population for patients randomized to pembrolizumab plus chemotherapy compared with cetuximab plus chemotherapy at a prespecified interim analysis.

    It also demonstrated statistically significant improvements in OS for the subgroups of patients randomized to pembrolizumab as a single agent compared with cetuximab plus chemotherapy. 

    There were no significant differences in progression-free survival for either pembrolizumab-containing arm compared with the cetuximab plus chemotherapy arm in any population.

    The most common adverse reactions of patients who received pembrolizumab as a single agent were fatigue, constipation, and rash. The most common adverse reactions in patients who received pembrolizumab in combination with chemotherapy were nausea, fatigue, constipation, vomiting, mucosal inflammation, diarrhea, decreased appetite, stomatitis, and cough.

    The recommended pembrolizumab dosage for HNSCC is 200 mg administered as an I.V. infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

  • June 21, 2019

    Amgen and Allergan announced FDA approval of trastuzumab-anns for treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The biosimilar is a recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody.

    Trastuzumab-anns was proven to be highly similar to and to have no clinically meaningful differences from the reference product, trastuzumab (Herceptin), based on extensive comparative analytical, pharmacokinetic, and clinical data.

    The biosimilar is the second of four biosimilars from Amgen and Allergan's collaboration to be approved by the FDA.

    The most common adverse reactions with treatment for breast cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

    In metastatic gastric cancer, the most common adverse reactions are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

  • June 21, 2019

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

    Efficacy was investigated in 83 patients with SCLC who had disease progression on or after two or more prior lines of therapy. The participants were enrolled in one of two multicenter, multicohort, nonrandomized, open-label trials: KEYNOTE-158 Cohort G or KEYNOTE-028 Cohort C1.

    Patients received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until documented disease progression, unacceptable toxicity, or a maximum of 24 months.

    The main efficacy outcome measures were overall response rate (ORR) and duration of response (modified RECIST v1.1) assessed by blinded independent central review. The ORR was 19% (95% CI 11–29); the complete response rate was 2%. Responses were durable for 6 months or longer in 94%, 12 months or longer in 63%, and 18 months or longer in 56% of the 16 responding patients.

    Adverse reactions in patients who received single-agent pembrolizumab for previously treated SCLC were similar to those occurring in patients with other solid tumors who received pembrolizumab. Common adverse reactions, reported in at least 20% of patients, included fatigue, decreased appetite, cough, nausea, and constipation.

    Pembrolizumab was discontinued for adverse reactions in 9% of patients, and 25% had at least one dose withheld for adverse reactions. Serious adverse reactions occurred in 31%. The most frequent (≥2%) serious adverse reactions were pneumonia and pleural effusion.

    The recommended pembrolizumab dose for SCLC is 200 mg administered as an I.V. infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

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