Search Results for "Contraceptives"
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Searched for Contraceptives. Results 51 to 60 of 118 total matches.
Enfortumab Vedotin (Padcev) for Urothelial Cancer (online only)
The Medical Letter on Drugs and Therapeutics • May 22, 2023 (Issue 1677)
of reproductive potential should
use effective contraception during treatment with
OTHER INDICATIONS ...
Enfortumab vedotin-ejfv (Padcev – Astellas), a
nectin-4-directed antibody and microtubule inhibitor
conjugate, has received accelerated approval
from the FDA for use with the immune checkpoint
inhibitor pembrolizumab (Keytruda) for treatment
of locally advanced or metastatic urothelial cancer
in adults who are ineligible for cisplatin-containing
chemotherapy. Accelerated approval was based on
tumor response rates and the durability of response.
Med Lett Drugs Ther. 2023 May 22;65(1677):e91-2 doi:10.58347/tml.2023.1677g | Show Introduction Hide Introduction
Epcoritamab (Epkinly) for Diffuse Large B-Cell Lymphoma (DLBCL) (online only)
The Medical Letter on Drugs and Therapeutics • Jun 12, 2023 (Issue 1678)
pregnancy or while
breastfeeding. Females of childbearing potential
should use effective contraception ...
Epcoritamab-bysp (Epkinly – Genmab), a bispecific
CD20-directed CD3 T-cell engager, has received
accelerated approval from the FDA for subcutaneous
treatment of relapsed or refractory diffuse large
B-cell lymphoma (DLBCL), not otherwise specified,
including DLBCL arising from indolent lymphoma,
and high-grade B-cell lymphoma after ≥2 lines
of systemic therapy. Epcoritamab is the second
T-cell-engaging bispecific antibody to become
available in the US for treatment of non-Hodgkin's
lymphoma; mosunetuzumab-axgb (Lunsumio) was
recently approved for relapsed or refractory...
Med Lett Drugs Ther. 2023 Jun 12;65(1678):e103-4 doi:10.58347/tml.2023.1678d | Show Introduction Hide Introduction
Talquetamab (Talvey) for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • Sep 04, 2023 (Issue 1684)
or while breastfeeding. Females
of childbearing potential should use effective
contraception during ...
Talquetamab-tgvs (Talvey – Janssen), a bispecific
GPRC5D-directed T-cell engager, has been granted
accelerated approval by the FDA 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. Accelerated
approval was based on the response rate and
durability of response. Talquetamab is the first
bispecific GPRC5D-directed T-cell engager to be
approved in the US
Med Lett Drugs Ther. 2023 Sep 4;65(1684):e149-50 doi:10.58347/tml.2023.1684e | Show Introduction Hide Introduction
Valoctocogene Roxaparvovec (Roctavian) – A Gene Therapy for Severe Hemophilia A
The Medical Letter on Drugs and Therapeutics • Oct 02, 2023 (Issue 1686)
contraception for
6 months after treatment.
The wholesale acquisition cost of one dose of
Roctavian for a 70 ...
Valoctocogene roxaparvovec-rvox (Roctavian –
Biomarin), an adeno-associated virus (AAV) vector-based
gene therapy, has been approved by the FDA
for one-time treatment of severe hemophilia A
in adults without pre-existing antibodies to AAV
serotype 5. It is the first gene therapy to be approved
in the US for treatment of hemophilia A.
Med Lett Drugs Ther. 2023 Oct 2;65(1686):157-8 doi:10.58347/tml.2023.1686c | Show Introduction Hide Introduction
Pitolisant (Wakix) for Narcolepsy
The Medical Letter on Drugs and Therapeutics • Feb 08, 2021 (Issue 1617)
CYP3A4 substrates, such as
oral contraceptives. Women should use nonhormonal
contraceptive methods ...
The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H3)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H3-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.
Clascoterone Cream (Winlevi) for Acne
The Medical Letter on Drugs and Therapeutics • Dec 27, 2021 (Issue 1640)
combination oral contraceptives, which
decrease androgen production, are often used to
treat acne in female ...
The FDA has approved Winlevi (Sun), a 1% cream
formulation of the androgen receptor inhibitor
clascoterone, for treatment of acne vulgaris in
patients ≥12 years old. It is the first topical androgen
receptor inhibitor to be approved by the FDA.
Avapritinib (Ayvakit) for GIST
The Medical Letter on Drugs and Therapeutics • Feb 08, 2021 (Issue 1617)
of reproductive potential and their male
partners should use effective contraception during
treatment ...
The FDA has approved the oral tyrosine kinase
inhibitor avapritinib (Ayvakit – Blueprint Medicines)
for treatment of unresectable or metastatic gastrointestinal
stromal tumors (GISTs) harboring a
platelet-derived growth factor receptor alpha
(PDGFRA) D842V or other PDGFRA exon 18 mutation.
Avapritinib is the first drug to be approved for this
indication in the US.
Pirtobrutinib (Jaypirca): A Fourth Bruton's Tyrosine Kinase Inhibitor for Mantle Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Feb 20, 2023 (Issue 1670)
pirtobrutinib; they should
use an effective nonhormonal contraceptive method
while taking the drug and for 1 ...
The Bruton's tyrosine kinase (BTK) inhibitor
pirtobrutinib (Jaypirca – Lilly) has received
accelerated approval from the FDA for treatment of
relapsed or refractory mantle cell lymphoma (MCL) in
adults who received ≥2 prior lines of systemic therapy,
including a BTK inhibitor. Accelerated approval was
based on the response rate. The BTK inhibitors
ibrutinib (Imbruvica), acalabrutinib (Calquence),
and zanubrutinib (Brukinsa) are also approved for
treatment of MCL.
Med Lett Drugs Ther. 2023 Feb 20;65(1670):e35-6 doi:10.58347/tml.2023.1670f | Show Introduction Hide Introduction
Mosunetuzumab (Lunsumio) for Follicular Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
or while breastfeeding. Women
of childbearing potential should use effective
contraception during ...
Mosunetuzumab-axgb (Lunsumio – Genentech),
a bispecific CD20-directed CD3 T-cell engager,
has received accelerated approval from the FDA
for treatment of relapsed or refractory follicular
lymphoma in adults who received ≥2 lines of systemic
therapy. It is the first T-cell-engaging bispecific
antibody to be approved in the US for this indication.
Med Lett Drugs Ther. 2023 Mar 6;65(1671):e41-2 doi:10.58347/tml.2023.1671f | Show Introduction Hide Introduction
Dostarlimab (Jemperli) for Endometrial Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
use effective
contraception during treatment with dostarlimab and
for 4 months after the last dose ...
The FDA has granted regular approval to dostarlimabgxly
(Jemperli – GSK), an immune checkpoint
inhibitor, for treatment of adults with mismatch repair
deficient (dMMR) recurrent or advanced endometrial
cancer that has progressed on or following a prior
platinum-containing regimen in any setting and who
are not candidates for curative surgery or radiation.
Dostarlimab received accelerated approval in 2021
for treatment of adults with dMMR recurrent or
advanced endometrial cancer or nonendometrial
solid tumors that progressed on or following prior
treatment and who have no...
Med Lett Drugs Ther. 2023 Apr 3;65(1673):e64-5 doi:10.58347/tml.2023.1673h | Show Introduction Hide Introduction