Medication Monitor

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  • 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.

  • June 21, 2019

    FDA approved liraglutide injection for treatment of pediatric patients aged 10 years or older with type 2 diabetes. The agent is the first noninsulin drug approved for this indication since metformin was approved for pediatric use in 2000. It has been approved for adult patients with type 2 diabetes since 2010.  

    While the drug is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, its effect on major adverse cardiovascular events in pediatrics was not studied, and it is not indicated for this use in children.  

    The prescribing information includes a boxed warning about the increased risk of thyroid C-cell tumors. The drug also carries warnings about pancreatitis; pen sharing; hypoglycemia when used with certain other drugs known to cause hypoglycemia, including insulin and sulfonylurea; renal impairment or kidney failure; hypersensitivity; and acute gallbladder disease. 

    The most common adverse effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

  • June 15, 2019

    FDA approved galcanezumab-gnlm solution for self-injection to treat episodic cluster headache in adults. The agent was first approved in September 2018 for prevention of migraine in adults.  

    Cluster headache is a form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. The headaches are accompanied by symptoms that may include bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion and facial sweating. Some people experience restlessness and agitation. Cluster headache attacks may strike several times a day, generally lasting between 15 minutes and 3 hours.   

    Hypersensitivity reactions with use of galcanezumab-gnlm could occur days after administration and may be prolonged. Treatment should be discontinued if this occurs. The most common adverse effect is injection site reactions.