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Omacetaxine (Synribo) for CML (online only)

   
The Medical Letter on Drugs and Therapeutics • May 25, 2015  (Issue 1469)
after interferon failure.1 Imatinib (Gleevec), the first tyrosine kinase inhibitor approved ...
The FDA has approved omacetaxine mepesuccinate (Synribo – Teva), a cephalotaxine known for many years as homoharringtonine, for treatment of adults with chronic or accelerated phase chronic myeloid leukemia (CML) who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors.
Med Lett Drugs Ther. 2015 May 25;57(1469):e80-81 | Show Introduction Hide Introduction

Afatinib (Gilotrif) for Advanced Non-Small Cell Lung Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • May 25, 2015  (Issue 1469)
% vs 6%), stomatitis/ mucositis (72% vs 15%), paronychia (57% vs 0%), dry skin (29% vs 1 ...
The FDA has approved afatinib (Gilotrif — Boehringer Ingelheim), an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations occur in about 10% of patients with NSCLC. Afatinib is the second EGFR inhibitor to be approved for first-line treatment of advanced lung cancer. The first was erlotinib (Tarceva), which is also approved for treatment of patients with locally advanced or metastatic...
Med Lett Drugs Ther. 2015 May 25;57(1469):e82-83 | Show Introduction Hide Introduction

Peginterferon Beta-1a (Plegridy) for Multiple Sclerosis

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
lesions seen on MRI.1 Second-line drugs are usually reserved for patients with severe disease ...
The FDA has approved a pegylated form of interferon beta-1a (Plegridy – Biogen) for biweekly treatment of patients with relapsing multiple sclerosis (MS).
Med Lett Drugs Ther. 2015 May 11;57(1468):67-9 | Show Introduction Hide Introduction

Concentrated Insulin Glargine (Toujeo) for Diabetes

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
the bioavailability of Toujeo.1,2 CLINICAL STUDIES — FDA approval of Toujeo was based on one open-label trial ...
The FDA has approved Toujeo (Sanofi), a more concentrated form of insulin glargine containing 300 IU/mL compared to the 100 IU/mL in Lantus (Sanofi). Lantus is nearing the end of its patent protection in the US, and biosimilars are expected to become available.
Med Lett Drugs Ther. 2015 May 11;57(1468):69-70 | Show Introduction Hide Introduction

Extended-Release Hydrocodone (Hysingla ER) for Pain

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
to discourage their misuse. Table 1. Some Extended-Release Oral Opioids Duration Drug Formulations Starting ...
The FDA has approved a second extended-release (ER) formulation of the oral opioid agonist hydrocodone (Hysingla ER – Purdue) for management of pain severe enough to require continuous long-term therapy and for which alternative treatment options are inadequate. Hysingla ER tablets have abuse-deterrent properties to discourage their misuse.
Med Lett Drugs Ther. 2015 May 11;57(1468):71-2 | Show Introduction Hide Introduction

Testosterone Nasal Gel (Natesto) for Hypogonadism

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
infarction (MI) and stroke.1 Pronunciation Key Testosterone: tes tos' ter one Natesto: na tes' toe ...
The FDA has approved an intranasal gel formulation of testosterone (Natesto – Trimel/Endo) for replacement therapy in men with hypogonadism. Packaged in a metered-dose pump, Natesto is the first intranasal testosterone to become available in the US. Like other testosterone products, it is classified as a schedule III controlled substance. The FDA recently cautioned against using testosterone to treat low testosterone levels solely due to aging because the benefits and safety of such use have not been established, and there is a possible increased risk of myocardial infarction (MI) and...
Med Lett Drugs Ther. 2015 May 11;57(1468):73-4 | Show Introduction Hide Introduction

Blinatumomab (Blincyto) for Acute Lymphoblastic Leukemia (online only)

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
with only partial hematological recovery of peripheral blood counts with a median duration of 5.0 months.1 ...
The FDA has approved blinatumomab (Blincyto – Onyx/Amgen) for treatment of relapsed or refractory Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (ALL).
Med Lett Drugs Ther. 2015 May 11;57(1468):e74-75 | Show Introduction Hide Introduction

Ramucirumab (Cyramza) for Gastric and GEJ Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
.2 vs. 3.8 months). Median progression-free survival was 2.1 months in patients who received ...
Ramucirumab (Cyramza – Lilly), a monoclonal antibody that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), has been approved by the FDA for use as monotherapy or in combination with paclitaxel for treatment of advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after platinum- or fluoropyrimidine-based chemotherapy. Ramucirumab is also approved for use in combination with docetaxel (Taxotere, and others) for treatment of metastatic non-small cell lung cancer that has progressed on or after platinum-based...
Med Lett Drugs Ther. 2015 May 11;57(1468):e74-75 | Show Introduction Hide Introduction

Idelalisib (Zydelig) for Chronic Lymphocytic Leukemia and Non-Hodgkins Lymphoma (online only)

   
The Medical Letter on Drugs and Therapeutics • May 11, 2015  (Issue 1468)
CLL usually includes fludarabine, rituximab, and cyclophosphamide (Cytoxan, and others).1 Combining ...
The FDA has approved idelalisib (Zydelig – Gilead), an oral kinase inhibitor, for use in combination with rituximab (Rituxan) for treatment of relapsed chronic lymphocytic leukemia (CLL). It is also approved as monotherapy for treatment of relapsed follicular lymphoma and relapsed small lymphocytic lymphoma (both are subtypes of indolent non-Hodgkins lymphoma) in patients who have received at least two prior systemic therapies.
Med Lett Drugs Ther. 2015 May 11;57(1468):e74-75 | Show Introduction Hide Introduction

Carbidopa/Levodopa Extended-Release Capsules (Rytary)

   
The Medical Letter on Drugs and Therapeutics • Apr 27, 2015  (Issue 1467)
relief of PD.1 It has been available for many years as immediate- and sustained-release tablets ...
The FDA has approved a new formulation of carbidopa/levodopa (Rytary – Impax) in extended-release capsules for treatment of Parkinson’s disease (PD).
Med Lett Drugs Ther. 2015 Apr 27;57(1467):59-60 | Show Introduction Hide Introduction