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In Brief: A New Endometrial Cancer Indication for Dostarlimab (Jemperli) (online only)
The Medical Letter on Drugs and Therapeutics • Aug 21, 2023 (Issue 1683)
for curative
surgery or radiation.1
MECHANISM OF ACTION — Binding of PD-L1 and
PD-L2 to programmed death ...
The immune checkpoint inhibitor dostarlimab-gxly
(Jemperli – GSK) has been approved by the FDA for
use in combination with carboplatin and paclitaxel
for treatment of adults with mismatch repair deficient
(dMMR) or microsatellite instability-high (MSI-H)
primary advanced or recurrent endometrial cancer.
Dostarlimab was recently granted regular approval
for treatment of adults with dMMR recurrent or
advanced endometrial cancer that progressed on
or following a prior platinum-containing regimen in
any setting and who are not candidates for curative
surgery or radiation.
Med Lett Drugs Ther. 2023 Aug 21;65(1683):e138 doi:10.58347/tml.2023.1683f | Show Introduction Hide Introduction
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • Mar 21, 2022 (Issue 1646)
are moderately to severely
immunocompromised1:
1. The recommended length of time between
completion of a 3 ...
The CDC has issued new guidance allowing for
an interval of up to 8 weeks between the first and
second primary doses of an mRNA COVID-19 vaccine
in certain patients 12-64 years old.1 Product labeling
currently recommends a 3-week interval between the
first two doses of the Pfizer/BioNTech mRNA vaccine
(Comirnaty) and a 4-week interval between the first
two doses of the Moderna mRNA vaccine (Spikevax).
The new guidance is based on data suggesting that
a longer interval can decrease the risk of myocarditis
and may improve vaccine efficacy.
Drugs for Postmenopausal Osteoporosis
The Medical Letter on Drugs and Therapeutics • Jul 13, 2020 (Issue 1602)
between -1.0 and -2.5 and a history of fragility
(low-trauma) fracture of the hip or spine, or a T-score ...
US guidelines recommend pharmacologic therapy for
postmenopausal women with a bone density T-score
(standard deviation from normal mean values in
healthy young women) of -2.5 or below in the lumbar
spine, femoral neck, total hip, or distal radius, a
T-score between -1.0 and -2.5 and a history of fragility
(low-trauma) fracture of the hip or spine, or a T-score
between -1.0 and -2.5 and a FRAX 10-year probability
of ≥3% for hip fracture or ≥20% for major osteoporotic
fracture (hip, clinical spine, humerus, distal radius).
Ciltacabtagene Autoleucel (Carvykti) for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • Nov 14, 2022 (Issue 1663)
-specific, single-dose infusion
bags containing up to 1×108 CAR-positive viable
T cells in a 30- or 70-mL ...
The FDA has approved ciltacabtagene autoleucel
(Carvykti – Janssen), 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. Carvykti 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. Idecabtagene...
Atezolizumab (Tecentriq) for Alveolar Soft Part Sarcoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
of non-small
cell lung cancer, small cell lung cancer, hepatocellular
cancer, and melanoma (see Table 1 ...
Atezolizumab (Tecentriq – Genentech), an immune
checkpoint inhibitor, has been approved by the FDA
for treatment of unresectable or metastatic alveolar
soft part sarcoma (ASPS) in patients ≥2 years old. It
was previously approved for treatment of non-small
cell lung cancer, small cell lung cancer, hepatocellular
cancer, and melanoma (see Table 1). Atezolizumab is
the first drug to be approved in the US for treatment
of ASPS. ASPS is a rare disorder that affects mostly
adolescents and young adults; <1% of soft tissue
sarcomas are ASPS.
Med Lett Drugs Ther. 2023 Apr 3;65(1673):e56-7 doi:10.58347/tml.2023.1673d | Show Introduction Hide Introduction
Sodium Sulfate-Based Tablets (Sutab) for Colonoscopy Preparation
The Medical Letter on Drugs and Therapeutics • Mar 08, 2021 (Issue 1619)
should be used in patients with
severe active ulcerative colitis.
Table 1. Sutab Clinical Trial Results ...
The FDA has approved an oral tablet formulation of
sodium sulfate, magnesium sulfate, and potassium
chloride (Sutab – Braintree) for colon cleansing prior
to colonoscopy in adults. A sodium sulfate-based oral
solution (Suprep) has been available in the US since
2010. Sutab is the second tablet formulation to be
approved for bowel cleansing prior to colonoscopy;
a sodium phosphate-based tablet (OsmoPrep) was
approved earlier.
In Brief: Semglee - Insulin Glargine Interchangeable with Lantus
The Medical Letter on Drugs and Therapeutics • Oct 04, 2021 (Issue 1634)
will be the same if the patient switches
between the reference product and the biosimilar.1
In an open-label ...
Insulin glargine-yfgn (Semglee – Viatris), a follow-on
insulin glargine product, has now received
interchangeability status with the reference product
Lantus from the FDA. It is the first biosimilar insulin
product to receive this designation in the US. Now a
pharmacist can substitute Semglee for Lantus as a
lower-cost alternative without permission from the
prescriber.
Eptinezumab (Vyepti) for Migraine Prevention
The Medical Letter on Drugs and Therapeutics • Jun 01, 2020 (Issue 1599)
once monthly (fremanezumab
can also be given once every 3 months), were
approved earlier.1 ...
The FDA has approved eptinezumab-jjmr (Vyepti –
Lundbeck), a calcitonin gene-related peptide (CGRP)
antagonist administered IV once every 3 months, for
migraine prevention in adults. It is the fourth monoclonal
antibody to be approved for this indication; erenumab
(Aimovig), fremanezumab (Ajovy), and galcanezumab
(Emgality), which are all given subcutaneously once
monthly (fremanezumab can also be given once every 3
months), were approved earlier.
Jatenzo - An Oral Testosterone for Hypogonadism
The Medical Letter on Drugs and Therapeutics • Jun 28, 2021 (Issue 1627)
.
TESTOSTERONE REPLACEMENT — Oral testosterone
replacement therapy has generally been ineffective
Table 1. Some ...
An oral formulation of testosterone undecanoate
(Jatenzo – Clarus) has been approved by the FDA for
treatment of adult men with conditions associated
with a deficiency of endogenous testosterone, such as
Klinefelter syndrome, orchiectomy, toxic damage from
chemotherapy or alcohol, or pituitary-hypothalamic
injury from tumors, trauma, or radiation. Jatenzo is
not approved for treatment of low testosterone levels
solely due to aging. It is the first oral testosterone
formulation to be approved in the US.
In Brief: Higher-Dose Naloxone Nasal Spray (Kloxxado) for Opioid Overdose
The Medical Letter on Drugs and Therapeutics • Sep 20, 2021 (Issue 1633)
mg per spray
(Narcan) was approved in 2015.1
Pronunciation Key
Kloxxado: kloks ah’ doh
Table 1 ...
The FDA has approved a higher-dose intranasal
naloxone formulation (Kloxxado – Hikma) for
emergency treatment of opioid overdose. A single
spray of the new formulation delivers 8 mg of
naloxone; a formulation that delivers 4 mg per spray
(Narcan) was approved in 2015.