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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...
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.
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.
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.
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.
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.
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.
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...
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).
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.