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Osimertinib (Tagrisso) for Adjuvant Treatment of NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Aug 07, 2023 (Issue 1682)
to IIIA disease, 5-year overall
survival was 88% with osimertinib and 78% with
placebo.1
ADVERSE ...
The FDA has approved osimertinib (Tagrisso –
AstraZeneca), an oral kinase inhibitor, for adjuvant
treatment of non-small cell lung cancer (NSCLC)
after tumor resection in adults who have epidermal
growth factor receptor (EGFR) exon 19 deletions or
exon 21 L858R mutations. Osimertinib is the first
targeted therapy to be approved in the US for this
indication. The drug was previously approved for
first-line treatment of adults with NSCLC with EGFR
exon 19 deletions or exon 21 L858R mutations and for
treatment of EGFR T790M mutation-positive NSCLC
in adults whose disease progressed...
Med Lett Drugs Ther. 2023 Aug 7;65(1682):e131-2 doi:10.58347/tml.2023.1682c | Show Introduction Hide Introduction
In Brief: Tafasitamab (Monjuvi) for Diffuse Large B-Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Aug 07, 2023 (Issue 1682)
on days 1 to 21 of each 28-day cycle) for up to
12 cycles, followed by tafasitamab alone until
disease ...
Tafasitamab-cxix (Monjuvi – Morphosys), a CD19-directed cytolytic antibody, has received accelerated
approval from the FDA for use in combination with
lenalidomide (Revlimid) for treatment of relapsed or
refractory diffuse large B-cell lymphoma (DLBCL),
not otherwise specified, including DLBCL arising from
low grade lymphoma, in adults who are not eligible
for autologous stem cell transplant. Accelerated
approval was based on overall response rates.
Med Lett Drugs Ther. 2023 Aug 7;65(1682):e133 doi:10.58347/tml.2023.1682d | Show Introduction Hide Introduction
Talazoparib (Talzenna) for Prostate Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Aug 07, 2023 (Issue 1682)
in another HR gene.
Table 1. Pharmacology
Class Poly(ADP-ribose) polymerase (PARP)
inhibitor
Formulation ...
The oral poly(ADP-ribose) polymerase (PARP)
inhibitor talazoparib (Talzenna – Pfizer) has been
approved by the FDA for use in combination with the
androgen receptor blocker enzalutamide (Xtandi) for
treatment of adults with homologous recombination
repair (HRR) gene-mutated metastatic castration-resistant
prostate cancer (mCRPC). The drug has
been available since 2018 for treatment of deleterious
or suspected deleterious germline BRCA-mutated
(gBRCAm), HER2-negative locally advanced or
metastatic breast cancer.
Med Lett Drugs Ther. 2023 Aug 7;65(1682):e134-5 doi:10.58347/tml.2023.1682e | Show Introduction Hide Introduction
Tofersen (Qalsody) for ALS
The Medical Letter on Drugs and Therapeutics • Jul 24, 2023 (Issue 1681)
(ALS) in adults who
have a mutation in the superoxide dismutase 1
(SOD1) gene. About 2% of patients ...
Tofersen (Qalsody – Biogen), an intrathecally
administered antisense oligonucleotide, has received
accelerated approval from the FDA for treatment of
amyotrophic lateral sclerosis (ALS) in adults who
have a mutation in the superoxide dismutase 1
(SOD1) gene. About 2% of patients with ALS have
mutations in the SOD1 gene. Tofersen is the first drug
to be approved in the US that targets a genetic cause
of ALS. Accelerated approval of the drug was based
on the surrogate endpoint of a reduction in plasma
neurofilament light chain, which is considered likely
to predict clinical...
Med Lett Drugs Ther. 2023 Jul 24;65(1681):113-4 doi:10.58347/tml.2023.1681a | Show Introduction Hide Introduction
Sotagliflozin (Inpefa) for Heart Failure
The Medical Letter on Drugs and Therapeutics • Jul 24, 2023 (Issue 1681)
), an oral sodium-glucose cotransporter
1 and 2 (SGLT1/2) inhibitor, to reduce the risk of
hospitalization ...
The FDA has approved sotagliflozin (Inpefa –
Lexicon), an oral sodium-glucose cotransporter
1 and 2 (SGLT1/2) inhibitor, to reduce the risk of
hospitalization for heart failure (HF), urgent HF visits,
and cardiovascular death in adults with either HF
(with any left ventricular ejection fraction [LVEF]) or
type 2 diabetes, chronic kidney disease (CKD), and
other cardiovascular risk factors. Sotagliflozin is
the first dual SGLT1/2 inhibitor to be approved in the
US. Unlike SGLT2 inhibitors, it is not FDA-approved
to improve glycemic control in adults with type 2
diabetes....
Med Lett Drugs Ther. 2023 Jul 24;65(1681):114-6 doi:10.58347/tml.2023.1681b | Show Introduction Hide Introduction
Zavegepant (Zavzpret) for Acute Treatment of Migraine
The Medical Letter on Drugs and Therapeutics • Jul 24, 2023 (Issue 1681)
prevention.1,2 Atogepant (Qulipta), another oral
CGRP receptor antagonist, and four parenterally ...
The FDA has approved zavegepant nasal spray
(Zavzpret – Pfizer) for acute treatment of migraine
with or without aura in adults. Zavzpret is the first
nasal spray formulation of a calcitonin gene-related
peptide (CGRP) receptor antagonist ("gepant") to
become available in the US.
Med Lett Drugs Ther. 2023 Jul 24;65(1681):116-8 doi:10.58347/tml.2023.1681c | Show Introduction Hide Introduction
Inspire for Obstructive Sleep Apnea
The Medical Letter on Drugs and Therapeutics • Jul 24, 2023 (Issue 1681)
1) for treatment with the surgically
implanted hypoglossal nerve stimulation system
(Inspire Upper ...
The FDA recently expanded the eligibility criteria
(see Table 1) for treatment with the surgically
implanted hypoglossal nerve stimulation system
(Inspire Upper Airway Stimulation – Inspire Medical
Systems). The device has been advertised lately on
radio and television.
Med Lett Drugs Ther. 2023 Jul 24;65(1681):118-20 doi:10.58347/tml.2023.1681d | Show Introduction Hide Introduction
Relugolix (Orgovyx) for Advanced Prostate Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Jul 24, 2023 (Issue 1681)
2008 for the same indication.1
Pronunciation and Abbreviation Key:
Relugolix: rel” ue goe’ lix ...
The oral gonadotropin-releasing hormone (GnRH)
receptor antagonist relugolix (Orgovyx – Myovant
Sciences/Pfizer) has been approved by the FDA for
treatment of advanced prostate cancer in adults. It
is the first oral GnRH receptor antagonist to become
available in the US; degarelix (Firmagon), an injectable
GnRH receptor antagonist, has been available since
2008 for the same indication.
Med Lett Drugs Ther. 2023 Jul 24;65(1681):e121-2 doi:10.58347/tml.2023.1681e | Show Introduction Hide Introduction
Drugs for Inflammatory Bowel Disease
The Medical Letter on Drugs and Therapeutics • Jul 10, 2023 (Issue 1680)
. Guidelines for treatment of UC and CD
have been updated in recent years.1,2
AMINOSALICYLATES ...
Ulcerative colitis (UC) and Crohn's disease (CD),
referred to collectively as inflammatory bowel disease
(IBD), are chronic immune-mediated inflammatory
conditions. Guidelines for treatment of UC and CD
have been updated in recent years
Med Lett Drugs Ther. 2023 Jul 10;65(1680):105-12 doi:10.58347/tml.2023.1680a | Show Introduction Hide Introduction
Table: Safety of Drugs for IBD in Pregnancy (online only)
The Medical Letter on Drugs and Therapeutics • Jul 10, 2023 (Issue 1680)
disease; JAK = Janus kinase; TNF = tumor necrosis factor
1. U Mahadevan et al. Gastroenterology 2019; 156 ...
View the Table: Safety of Drugs for IBD in Pregnancy
Med Lett Drugs Ther. 2023 Jul 10;65(1680):e113 doi:10.58347/tml.2023.1680b | Show Introduction Hide Introduction