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COVID-19 Update: Pfizer Bivalent Vaccine Booster Dose for Children 6 Months to 4 Years Old
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
) for children
6 months to 5 years old were authorized earlier.1,2
CLINICAL STUDIES — Expansion of the EUA ...
The FDA has expanded its Emergency Use
Authorization (EUA) for the COVID-19 vaccine
manufactured by Pfizer/BioNTech (Comirnaty) to
permit use of the bivalent formulation (containing
mRNA from the original and BA.4/5 Omicron strains of
SARS-CoV-2) as a booster dose in children 6 months
to 4 years old who completed the primary series with
3 doses of the monovalent formulation ≥2 months
previously. The Pfizer bivalent vaccine had previously
been authorized for use as a booster dose in persons
≥5 years old and as a third primary dose in children 6
months to 4 years old. Booster...
Med Lett Drugs Ther. 2023 Apr 17;65(1674):63-4 doi:10.58347/tml.2023.1674c | Show Introduction Hide Introduction
Capmatinib (Tabrecta) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
for the same indication in 2020
based on initial overall response rates and duration
of response.1
ADVERSE ...
The FDA has granted regular approval to the oral
kinase inhibitor capmatinib (Tabrecta – Novartis) for
treatment of metastatic non-small cell lung cancer
(NSCLC) in adults whose tumors have a mutation that
leads to mesenchymal-epithelial transition (MET)
exon 14 skipping. MET exon 14 skipping mutations
occur in 3-4% of NSCLC cases. The drug received
accelerated approval for the same indication in 2020
based on initial overall response rates and duration
of response.
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e65-6 doi:10.58347/tml.2023.1674d | Show Introduction Hide Introduction
Cemiplimab (Libtayo) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
in overall survival
were observed in patients with non-squamous and
squamous NSCLC.1
In one meta-analysis ...
The FDA has approved cemiplimab-rwlc (Libtayo –
Regeneron), an immune checkpoint inhibitor, for use in
combination with platinum-based chemotherapy for
first-line treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) in adults with no
epidermal growth factor receptor (EGFR), anaplastic
lymphoma kinase (ALK), or ROS1 aberrations and
who are not candidates for surgical resection or
chemoradiation. The drug was previously approved
for first-line treatment of NSCLC in patients whose
tumors have high PD-L1 expression and no genomic
tumor aberrations....
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e67-8 doi:10.58347/tml.2023.1674e | Show Introduction Hide Introduction
Futibatinib (Lytgobi) for Cholangiocarcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
; pemigatinib (Pemazyre)
was approved earlier.1
rearrangements, including fusions. Patients received ...
The oral kinase inhibitor futibatinib (Lytgobi –
Taiho) has received accelerated approval from the
FDA for treatment of adults with previously treated,
unresectable, locally advanced or metastatic
intrahepatic cholangiocarcinoma with fibroblast
growth factor receptor 2 (FGFR2) fusions or other
rearrangements. Accelerated approval was based
on the overall response rate and duration of
response. Futibatinib is the second drug to be
approved for this indication; pemigatinib (Pemazyre)
was approved earlier.
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e69-70 doi:10.58347/tml.2023.1674f | Show Introduction Hide Introduction
In Brief: A New Indication for Pemigatinib (Pemazyre) (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
myeloid/lymphoid neoplasms (MLNs) with fibroblast growth
factor receptor 1 (FGFR1) rearrangements ...
The oral kinase inhibitor pemigatinib (Pemazyre –
Incyte) has been approved by the FDA for treatment
of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth
factor receptor 1 (FGFR1) rearrangements. It is the
first targeted therapy to be approved in the US for this
indication. The drug received accelerated approval
from the FDA in 2020 for treatment of adults with
previously treated, unresectable, locally advanced or
metastatic cholangiocarcinoma with FGFR2 fusions
or other rearrangements.
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e71-2 doi:10.58347/tml.2023.1674g | Show Introduction Hide Introduction
In Brief: Retifanlimab (Zynyz) for Merkel Cell Carcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
), a programmed
death receptor-1 (PD-1) blocking antibody, has
received accelerated approval from the FDA ...
Retifanlimab-dlwr (Zynyz – Incyte), a programmed
death receptor-1 (PD-1) blocking antibody, has
received accelerated approval from the FDA for
treatment of metastatic or recurrent locally advanced
Merkel cell carcinoma (MCC) in adults. Accelerated
approval of the drug was based on the response rate
and duration of response. Retifanlimab is the third
drug to be approved in the US for treatment of MCC;
pembrolizumab (Keytruda), a PD-1 blocking antibody,
is approved for the same indication as retifanlimab
in patients ≥12 years old and avelumab (Bavencio),
a programmed death...
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e73-4 doi:10.58347/tml.2023.1674h | Show Introduction Hide Introduction
In Brief: Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Glioma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
in patients ≥1 years old
who require systemic therapy.1,2 This combination is
the first systemic therapy ...
The oral kinase inhibitors dabrafenib (Tafinlar –
GSK) and trametinib (Mekinist – Novartis) have been
approved by the FDA for use together for a sixth
indication: treatment of low-grade glioma (LGG)
with a BRAF V600E mutation in patients ≥1 years old
who require systemic therapy. This combination is
the first systemic therapy to be approved in the US
for first-line treatment of LGG with a BRAF V600E
mutation in pediatric patients. The FDA also approved
new oral formulations of both drugs for patients
who are unable to swallow dabrafenib capsules or
trametinib...
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e75-6 doi:10.58347/tml.2023.1674i | Show Introduction Hide Introduction
In Brief: Olaparib (Lynparza) for High-Risk Early Breast Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
, pancreatic, and
prostate cancers.1,2 It was previously approved for
treatment of adults with deleterious ...
The oral poly(ADP-ribose) polymerase (PARP)
inhibitor olaparib (Lynparza – AstraZeneca) has been
approved by the FDA for adjuvant treatment of adults
with deleterious or suspected deleterious germline
BRCA-mutated (gBRCAm), human epidermal growth
factor receptor 2 (HER2)-negative, high-risk early
breast cancer who received prior neoadjuvant or
adjuvant chemotherapy. The drug was previously
approved for treatment of adults with deleterious
or suspected deleterious gBRCAm, HER2-negative
metastatic breast cancer who received chemotherapy
in the neoadjuvant, adjuvant, or metastatic...
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e77-8 doi:10.58347/tml.2023.1674j | Show Introduction Hide Introduction
In Brief: Rezvoglar - Another Insulin Glargine Product Interchangeable with Lantus
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
in
the US on April 1, 2023. It is the second biosimilar
insulin product to be designated as interchangeable ...
Insulin glargine-aglr (Rezvoglar – Lilly), which was
approved by the FDA as a biosimilar to the reference
product Lantus in 2021 and received interchangeability
status with Lantus in 2022, will become available in
the US on April 1, 2023. It is the second biosimilar
insulin product to be designated as interchangeable
with Lantus; Semglee was the first. Rezvoglar did not
receive interchangeability status with Lantus at the
time of its initial approval because the manufacturer
of Semglee had exclusivity for 12 months.
Med Lett Drugs Ther. 2023 Apr 3;65(1673):56 doi:10.58347/tml.2023.1673c | Show Introduction Hide Introduction
Pegcetacoplan (Syfovre) for Geographic Atrophy in Age-Related Macular Degeneration
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
and can eventually develop
severe vision loss.1 There has been no established
treatment for dry AMD ...
The FDA has approved the complement C3 inhibitor
pegcetacoplan (Syfovre – Apellis) for treatment of
geographic atrophy (GA) secondary to age-related
macular degeneration (AMD). Given as a series of
monthly or every-other-month (EOM) intravitreal
injections, it is the first drug to become available for
use in patients with atrophic dry AMD. Subcutaneous
pegcetacoplan was approved earlier as Empaveli for
treatment of paroxysmal nocturnal hemoglobinuria.
Med Lett Drugs Ther. 2023 Apr 3;65(1673):49-50 doi:10.58347/tml.2023.1673a | Show Introduction Hide Introduction