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In Brief: Expanded Heart Failure Indication for Empagliflozin (Jardiance)
The Medical Letter on Drugs and Therapeutics • Apr 18, 2022 (Issue 1648)
(HFrEF; LVEF ≤40%),
regardless of whether or not they have type 2
diabetes.1 The indication has now ...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim)
was approved by the FDA in 2021 to reduce the
risk of hospitalization for heart failure (HF) and
cardiovascular death in patients with heart failure
with reduced ejection fraction (HFrEF; LVEF ≤40%),
regardless of whether or not they have type 2
diabetes. The indication has now been expanded to
include patients with HF with any ejection fraction.
Empagliflozin is the first SGLT2 inhibitor to be
approved in the US for this indication.
In Brief: Furoscix - A Subcutaneous Furosemide Infusor for Heart Failure
The Medical Letter on Drugs and Therapeutics • Jan 23, 2023 (Issue 1668)
diuretic resistance.1
EFFICACY AND SAFETY — FDA approval of the of the
new formulation was based ...
The FDA has approved Furoscix (scPharmaceuticals),
a subcutaneous formulation of the loop diuretic
furosemide administered via a single-use, on-body
infusor, for treatment of congestion due to fluid
overload in adults with New York Heart Association
(NYHA) Class II-III chronic heart failure (HF).
Furosemide (Lasix, and generics) has been available
for years in oral and IV formulations.
Med Lett Drugs Ther. 2023 Jan 23;65(1668):14-5 doi:10.58347/tml.2023.1668d | Show Introduction Hide Introduction
COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • Jan 09, 2023 (Issue 1667)
supplemental oxygen,
mechanical ventilation, or extracorporeal membrane
oxygenation (ECMO).1 Tocilizumab ...
The interleukin-6 (IL-6) receptor antagonist
tocilizumab (Actemra – Genentech) has been
approved by the FDA for IV treatment of COVID-19
in hospitalized adults who are receiving a systemic
corticosteroid and require supplemental oxygen,
mechanical ventilation, or extracorporeal membrane
oxygenation (ECMO). Tocilizumab was previously
available for this indication under an Emergency
Use Authorization (EUA); it remains available under
an EUA for treatment of children 2-17 years old
who are hospitalized with COVID-19 and require
oxygen support.
Med Lett Drugs Ther. 2023 Jan 9;65(1667):e9 doi:10.58347/tml.2023.1667d | Show Introduction Hide Introduction
In Brief: Adstiladrin – A Gene Therapy for Bladder Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
. The median duration of response was 9.7
months.1
ADVERSE EFFECTS — The most common adverse
effects ...
Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy,
has been approved by the FDA for treatment of adults
with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer
(NMIBC) with carcinoma in situ with or without
papillary tumors. It is the first adenoviral vector-based
gene therapy to be approved in the US for
this indication. The immune checkpoint inhibitor
pembrolizumab (Keytruda) was approved for the
same indication in 2021.
Med Lett Drugs Ther. 2023 Mar 6;65(1671):e40-1 doi:10.58347/tml.2023.1671e | Show Introduction Hide Introduction
In Brief: Prevention of Measles
The Medical Letter on Drugs and Therapeutics • Jun 09, 2025 (Issue 1730)
whose vaccination history was unknown.1
TRANSMISSION — The measles virus can be
transmitted by direct ...
According to the Centers for Disease Control (CDC),
as of April 24 there have been 844 confirmed cases of
measles in the US in 2025; 11% of cases have resulted
in hospitalization and 3 patients have died. The majority
of cases (96%) have been in unvaccinated persons or in
those whose vaccination history was unknown
Med Lett Drugs Ther. 2025 Jun 9;67(1730):94-5 doi:10.58347/tml.2025.1730d | Show Introduction Hide Introduction
In Brief: Abemaciclib (Verzenio) for Early Breast Cancer
The Medical Letter on Drugs and Therapeutics • Dec 13, 2021 (Issue 1639)
,
early breast cancer at high risk of recurrence
and a Ki-67 score >20%.1
HR-POSITIVE, HER2-NEGATIVE ...
The oral cyclin-dependent kinase (CDK) 4/6 inhibitor
abemaciclib (Verzenio – Lilly), which was approved
by the FDA in 2017 for treatment of hormone receptor
(HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or metastatic
breast cancer, has now been approved for use in
combination with endocrine therapy (tamoxifen or
an aromatase inhibitor) for adjuvant treatment of
patients with HR-positive, HER2-negative, node-positive,
early breast cancer at high risk of recurrence
and a Ki-67 score ≥20%.
Efgartigimod alfa (Vyvgart) for Myasthenia Gravis
The Medical Letter on Drugs and Therapeutics • Apr 18, 2022 (Issue 1648)
complement inhibitor eculizumab (Soliris) was
approved for the same indication in 2017.
Table 1 ...
Efgartigimod alfa-fcab (Vyvgart – Argenx), a first-in-class neonatal Fc receptor (FcRn) antagonist,
has been approved by the FDA for IV treatment of
generalized myasthenia gravis in adults who are
anti-acetylcholine receptor (AChR) antibody positive.
The IV complement inhibitor eculizumab (Soliris) was
approved for the same indication in 2017.
Idecabtagene Vicleucel (Abecma) for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • Nov 14, 2022 (Issue 1663)
a complete response or better. Median
progression-free survival was 8.8 months.1 A longterm
follow-up study ...
The FDA has approved idecabtagene vicleucel
(Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for
treatment of relapsed or refractory multiple myeloma in
adults who received ≥4 prior lines of therapy, including
a proteasome inhibitor, an immunomodulatory drug,
and an anti-CD38 monoclonal antibody. Abecma is
an individualized cellular product prepared from the
patient’s own T cells, which are genetically modified
to express chimeric antigen receptors (CAR) and
then infused back into the patient. Ciltacabtagene
autoleucel...
Polatuzumab vedotin (Polivy) for Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
, and prednisone (R-CHOP). The risk
of relapse is highest within one year following
treatment.1
MECHANISM ...
Polatuzumab vedotin-piiq (Polivy – Genentech), a
CD79b-directed antibody and microtubule inhibitor
conjugate, has been approved by the FDA for use
in combination with rituximab, cyclophosphamide,
doxorubicin, and prednisone (R-CHP) for first-line
treatment of diffuse large B-cell lymphoma
(DLBCL), not otherwise specified (NOS), or high-grade
B-cell lymphoma (HGBL) in adults who have
an International Prognostic Index (IPI) score ≥2. The
drug was previously approved for use in combination
with bendamustine and rituximab for treatment of
patients with relapsed or refactory DLBCL,...
Med Lett Drugs Ther. 2023 May 29;65(1677):e89-90 doi:10.58347/tml.2023.1677f | Show Introduction Hide Introduction
Asciminib (Scemblix) for Chronic Myeloid Leukemia (online only)
The Medical Letter on Drugs and Therapeutics • Jun 12, 2023 (Issue 1678)
of tyrosine kinase inhibitors will need a change
in their treatment regimen by 5 years.1
MECHANISM OF ACTION ...
Asciminib (Scemblix – Novartis), an oral kinase
inhibitor, has been approved by the FDA for treatment
of adults with Philadelphia chromosome-positive
chronic myeloid leukemia (Ph+ CML) in chronic
phase (CP) previously treated with ≥2 tyrosine kinase
inhibitors and for adults with Ph+ CML in CP with a
T315I mutation.
Med Lett Drugs Ther. 2023 Jun 12;65(1678):e107-8 doi:10.58347/tml.2023.1678g | Show Introduction Hide Introduction