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Addendum: Nivolumab (Opdivo) for Metastatic Melanoma and Metastatic NSCLC

   
The Medical Letter on Drugs and Therapeutics • Jun 22, 2015  (Issue 1471)
) was published in the most recent issue of The Medical Letter (June 8, 2015),1 some new data became available ...
After our article on nivolumab (Opdivo – BMS) for treatment of metastatic melanoma and metastatic squamous non-small cell lung cancer (NSCLC) was published in the most recent issue of The Medical Letter (June 8, 2015),1 some new data became available supporting the efficacy of the drug in previously untreated melanoma and previously treated nonsquamous NSCLC.MELANOMA – In a double-blind trial, 945 patients with previously untreated, unresectable stage III or IV melanoma were randomized to receive ipilimumab, nivolumab, or combination therapy with ipilimumab and nivolumab. Progression-free...
Med Lett Drugs Ther. 2015 Jun 22;57(1471):94 | Show Introduction Hide Introduction

Nivolumab (Opdivo) for Metastatic Melanoma and Metastatic NSCLC

   
The Medical Letter on Drugs and Therapeutics • Jun 08, 2015  (Issue 1470)
death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma ...
The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.
Med Lett Drugs Ther. 2015 Jun 8;57(1470):85-7 | Show Introduction Hide Introduction

Recombinant Human Parathyroid Hormone (Natpara)

   
The Medical Letter on Drugs and Therapeutics • Jun 08, 2015  (Issue 1470)
serum calcium, parathyroid hormone binds to PTH-1 receptors both in bone, causing release of calcium ...
The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.
Med Lett Drugs Ther. 2015 Jun 8;57(1470):87-8 | Show Introduction Hide Introduction

Ceftazidime/Avibactam (Avycaz) - A New Intravenous Antibiotic

   
The Medical Letter on Drugs and Therapeutics • May 25, 2015  (Issue 1469)
(Zerbaxa – Cubist), another cephalosporin/beta-lactamase inhibitor combination, was approved in 2014.1 ...
The FDA has approved ceftazidime/avibactam (Avycaz – Actavis) for IV treatment of complicated urinary tract and intra-abdominal infections in adults who have limited or no other treatment options. Ceftolozane/tazobactam (Zerbaxa – Cubist), another cephalosporin/beta-lactamase inhibitor combination, was approved in 2014.
Med Lett Drugs Ther. 2015 May 25;57(1469):79-80 | Show Introduction Hide Introduction

Fluticasone Furoate (Arnuity Ellipta) for Asthma

   
The Medical Letter on Drugs and Therapeutics • May 25, 2015  (Issue 1469)
-agonist vilanterol as Breo Ellipta for treatment of asthma and COPD.1 Pronunciation Key Fluticasone ...
The FDA has approved Arnuity Ellipta (GSK), a single-agent inhaler containing the corticosteroid fluticasone furoate, for once-daily maintenance treatment of asthma in patients ≥12 years old. Fluticasone furoate is also available in combination with the long-acting beta2-agonist vilanterol as Breo Ellipta for treatment of asthma and COPD.
Med Lett Drugs Ther. 2015 May 25;57(1469):76-9 | Show Introduction Hide Introduction

Ivabradine (Corlanor) for Heart Failure

   
The Medical Letter on Drugs and Therapeutics • May 25, 2015  (Issue 1469)
not reduce mortality.1 MECHANISM OF ACTION — Ivabradine slows heart rate by inhibiting the cardiac ...
The FDA has approved ivabradine (Corlanor – Amgen) to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35% who are in sinus rhythm with a resting heart rate ≥70 beats per minute and who are on maximum tolerated doses of beta blockers or have a contraindication to beta blocker use. Ivabradine has been available internationally for years as Procoralan and Corlentor for treatment of stable angina and heart failure.
Med Lett Drugs Ther. 2015 May 25;57(1469):75-6 | Show Introduction Hide Introduction

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):e80-1 | 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...
Med Lett Drugs Ther. 2015 May 25;57(1469):e82-3 | 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

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