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Zanidatamab (Ziihera) for Biliary Tract Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Jan 20, 2025 (Issue 1720)
% of intrahepatic
cholangiocarcinomas.1 Amplification and/or overexpression
of HER2 is associated with more ...
Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval
from the FDA for treatment of unresectable or metastatic
HER2-positive (IHC 3+) biliary tract cancer in patients
who received prior therapy. Biliary tract cancer includes
gallbladder cancer and intrahepatic and extrahepatic
cholangiocarcinoma. Zanidatamab is the first dual
HER2-targeted therapy to be approved in the US for
this indication. Accelerated approval was based on the
overall response rate and duration of response.
Med Lett Drugs Ther. 2025 Jan 20;67(1720):e16-7 doi:10.58347/tml.2025.1720f | Show Introduction Hide Introduction
In Brief: New Warning for the RSV Vaccines Arexvy and Abrysvo
The Medical Letter on Drugs and Therapeutics • Feb 17, 2025 (Issue 1722)
through 6 months of age.1,2
GBS — According to the CDC, 3000-6000 cases of GBS
are reported annually ...
The FDA has required a new warning in the labels of the
recombinant respiratory syncytial virus (RSV) vaccines
Arexvy (GSK) and Abrysvo (Pfizer) about an increased
risk of Guillain-Barré syndrome (GBS) within 42 days
of administration of either vaccine. Both vaccines
are FDA-approved to prevent lower respiratory tract
disease (LRTD) caused by RSV in adults.Abrysvo is
also approved for use in pregnant women at 32-36
weeks' gestation to prevent RSV-associated LRTD in
their infants from birth through 6 months of age.
Med Lett Drugs Ther. 2025 Feb 17;67(1722):31-2 doi:10.58347/tml.2025.1722d | Show Introduction Hide Introduction
In Brief: Safety of Quinine
The Medical Letter on Drugs and Therapeutics • Nov 01, 2010 (Issue 1350)
The Medical Letter®
On Drugs and Therapeutics
Volume 52 (Issue 1350)
November 1, 2010 ...
Qualaquin, the only formulation of quinine sulfate available in the US, is approved only for treatment of uncomplicated malaria, but most prescriptions for its use are written for treatment or prevention of nocturnal leg cramps. The FDA recently issued a warning about its safety.Between April 2005 and October 2008, 38 cases of serious or life-threatening adverse effects of quinine were reported to the FDA. Twenty-one of these patients had thrombocytopenia and required hospitalization. Two deaths were reported: one from hemolysis and the other from thrombotic thrombocytopenic purpura (TTP)....
In Brief: Nesiritide (Natrecor)
The Medical Letter on Drugs and Therapeutics • Nov 14, 2011 (Issue 1377)
use in the broad population of
patients with acute heart failure.”1 The editorialist
lamented ...
A recent editorial in The New England Journal of Medicine commented on the negative results of a clinical trial (published in the same issue) of nesiritide, a drug that had been approved by the FDA in 2001 (conditionally approved by Health Canada in 2007) for relief of dyspnea in patients with acutely decompensated heart failure. The authors of the recent clinical trial concluded: "On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure."1 The editorialist lamented the inadequacy of the data that had led to...
In Brief: Severe Hypersensitivity Reactions with Rolapitant IV Emulsion (Varubi)
The Medical Letter on Drugs and Therapeutics • Jan 29, 2018 (Issue 1539)
that the IV emulsion formulation of
the substance P/neurokinin 1 (NK1) receptor antagonist
rolapitant ...
The FDA has warned that the IV emulsion formulation of the substance P/neurokinin 1 (NK1) receptor antagonist rolapitant (Varubi) has been associated in postmarketing reports with serious hypersensitivity reactions including anaphylaxis and anaphylactic shock.1 Rolapitant was approved by the FDA as an oral tablet in 2015 for adjunctive prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults2; the IV emulsion formulation of the drug was approved for the same indication in 2017.The reported hypersensitivity reactions occurred during or shortly after infusion of...
Esketamine Nasal Spray (Spravato) for Treatment-Resistant Depression
The Medical Letter on Drugs and Therapeutics • Apr 08, 2019 (Issue 1569)
,
triiodothyronine, or lithium.1
Electroconvulsive therapy (ECT) is often effective
for treatment of severe ...
The FDA has approved esketamine (Spravato –
Janssen), an N-methyl-D-aspartate (NMDA) receptor
antagonist, for intranasal treatment (in conjunction
with an oral antidepressant) of adults with treatment-resistant
depression (TRD). This is the first FDA
approval for esketamine, which is the S-enantiomer
of the intravenous anesthetic ketamine (Ketalar,
and generics). In recent years, IV ketamine has been
increasingly used (off-label) for treatment of TRD.
Table: Treatments Considered for COVID-19 (Archived) (online only)
The Medical Letter on Drugs and Therapeutics • Apr 06, 2020 (Issue 1595)
2 days, then 500 mg once/day x 12 days2,3
OR
1 g on day 1, then 500mg once daily x 4-7days ...
View the Table: Treatments Considered for COVID-19
Abatacept (Orencia) for Rheumatoid Arthritis
The Medical Letter on Drugs and Therapeutics • Feb 27, 2006 (Issue 1229)
in the
treatment of RA.
1
Methotrexate is generally the
DMARD of choice. The tumor necrosis factor (TNF ...
Atacept (Orencia - Bristol-Myers Squibb), an inhibitor of T-cell activation, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA) in patients who have not responded to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Fenofibric Acid (Trilipix)
The Medical Letter on Drugs and Therapeutics • May 04, 2009 (Issue 1311)
and to fenofibric acid
monotherapy in lowering LDL-C.
1-3
Patients were not
required to be on an optimal dose ...
The FDA has approved the marketing of fenofibric acid (Trilipix - Abbott) to reduce triglycerides and increase HDL-C in patients with mixed dyslipidemia on optimal doses of a HMG-CoA reductase inhibitor (statin) who have, or have risk factors for, coronary heart disease. It is the first fibrate approved by the FDA specifically for combined use with a statin. Trilipix is also approved as monotherapy for hypertriglyceridemia, hypercholesterolemia and low HDL-C. The patent for Tricor, Abbott's older formulation of fenofibrate, will expire in 2011.
Iloperidone (Fanapt) - Another Second-Generation Antipsychotic
The Medical Letter on Drugs and Therapeutics • Feb 22, 2010 (Issue 1332)
antagonism
Route Oral
Formulation 1, 2, 4, 6, 8, 10 and 12 mg tablets
Tmax 2-4 hours
Steady state 3-4 ...
The FDA has approved the marketing of iloperidone (Fanapt – Vanda), a second-generation antipsychotic, for treatment of schizophrenia. Iloperidone is chemically related to risperidone (Risperdal, and others).