Matching articles for "trametinib"
Tovorafenib (Ojemda) for Pediatric Low-Grade Glioma (online only)
The Medical Letter on Drugs and Therapeutics • June 10, 2024; (Issue 1704)
Tovorafenib (Ojemda – Day One), a type II RAF kinase
inhibitor, has received accelerated approval from the
FDA for treatment of patients ≥6 months old with
relapsed or refractory pediatric low-grade...
Tovorafenib (Ojemda – Day One), a type II RAF kinase
inhibitor, has received accelerated approval from the
FDA for treatment of patients ≥6 months old with
relapsed or refractory pediatric low-grade glioma
harboring a BRAF fusion or rearrangement or a BRAF
V600 mutation. Tovorafenib is the first systemic
treatment to be approved in the US for pediatric
low-grade gliomas with BRAF fusions. Accelerated
approval of tovorafenib was based on response rates
and duration of response.
Lifileucel (Amtagvi): A Cellular Therapy for Melanoma (online only)
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
Lifileucel (Amtagvi – Iovance), a tumor-derived
autologous T-cell immunotherapy, has received
accelerated approval from the FDA for one-time
treatment of adults with unresectable or metastatic
melanoma...
Lifileucel (Amtagvi – Iovance), a tumor-derived
autologous T-cell immunotherapy, has received
accelerated approval from the FDA for one-time
treatment of adults with unresectable or metastatic
melanoma previously treated with a programmed
death receptor-1 (PD-1) inhibitor, and if BRAF V600
mutation-positive, a BRAF inhibitor with or without
a mitogen-activated kinase (MEK) inhibitor. It is the
first cellular therapy to be approved for use in solid
tumors. Accelerated approval of lifileucel was based
on objective response rates.
In Brief: Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Glioma (online only)
The Medical Letter on Drugs and Therapeutics • April 17, 2023; (Issue 1674)
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...
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 tablets.
In Brief: A New Indication for Dabrafenib (Tafinlar) and Trametinib (Mekinist) Combination Therapy (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of...
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of unresectable or
metastatic solid tumors with a BRAF V600E mutation
in patients ≥6 years old who have progressed
following prior treatment and have no satisfactory
alternative treatment options. The combination is not
approved for treatment of colorectal cancer because
of known intrinsic resistance to BRAF inhibition and
dabrafenib is not approved for use in patients with
wild-type BRAF melanoma, anaplastic thyroid cancer
(ATC), or solid tumors.
Opdualag for Metastatic Melanoma (online only)
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
Opdualag (BMS), a fixed-dose combination of two
immune checkpoint inhibitors — nivolumab (Opdivo),
a programmed death receptor-1 (PD-1) inhibitor, and
relatlimab-rmbw, a lymphocyte-activation...
Opdualag (BMS), a fixed-dose combination of two
immune checkpoint inhibitors — nivolumab (Opdivo),
a programmed death receptor-1 (PD-1) inhibitor, and
relatlimab-rmbw, a lymphocyte-activation gene-3
(LAG-3) blocking antibody — has been approved by
the FDA for treatment of unresectable or metastatic
melanoma in patients ≥12 years old. Relatlimab, which
is only available in combination with nivolumab, is
the first LAG-3 blocking antibody to become available
in the US. Immune checkpoint inhibitors, including
the anti-CTLA-4 antibody ipilimumab (Yervoy) and
the PD-1 inhibitors nivolumab and pembrolizumab
(Keytruda), have been available for several years for
treatment of melanoma.
Cobimetinib (Cotellic) for Metastatic Melanoma
The Medical Letter on Drugs and Therapeutics • March 28, 2016; (Issue 1491)
The FDA has approved the mitogen-activated
extracellular signal-regulated kinase (MEK) inhibitor
cobimetinib (Cotellic – Genentech) for use in combination
with the BRAF kinase inhibitor...
The FDA has approved the mitogen-activated
extracellular signal-regulated kinase (MEK) inhibitor
cobimetinib (Cotellic – Genentech) for use in combination
with the BRAF kinase inhibitor vemurafenib
(Zelboraf) for treatment of unresectable or metastatic
melanoma with a BRAF V600E or V600K mutation.
Nivolumab (Opdivo) for Metastatic Melanoma and Metastatic NSCLC
The Medical Letter on Drugs and Therapeutics • June 8, 2015; (Issue 1470)
The FDA has approved nivolumab (Opdivo – BMS),
an IV programmed death receptor-1 (PD-1) blocking
antibody, for treatment of unresectable or metastatic
melanoma that has progressed following treatment
with...
The FDA has approved nivolumab (Opdivo – BMS),
an IV programmed death receptor-1 (PD-1) blocking
antibody, for treatment of unresectable or metastatic
melanoma that has progressed following treatment
with ipilimumab (and a BRAF inhibitor in patients who
are BRAF V600 mutation positive) and for treatment
of metastatic squamous non-small cell lung cancer
(NSCLC) that has progressed on or after platinum-based
chemotherapy. It is the second PD-1 inhibitor to
be marketed in the US after pembrolizumab (Keytruda),
and the first to be approved for treatment of NSCLC.
Pembrolizumab (Keytruda) for Metastatic Melanoma (online only)
The Medical Letter on Drugs and Therapeutics • November 10, 2014; (Issue 1455)
The FDA has approved pembrolizumab (Keytruda –
Merck), a human programmed death receptor-1 (PD-1)
blocking antibody, for treatment of unresectable or
metastatic melanoma that has progressed...
The FDA has approved pembrolizumab (Keytruda –
Merck), a human programmed death receptor-1 (PD-1)
blocking antibody, for treatment of unresectable or
metastatic melanoma that has progressed following
treatment with ipilimumab (Yervoy) and, if the patient
is BRAF V600 mutation positive, a BRAF inhibitor. It
is the fi rst PD-1 inhibitor to be marketed in the US.
Nivolumab, another PD-1 inhibitor, is available in
Japan. Pembrolizumab was previously known as
lambrolizumab.
Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Metastatic Melanoma
The Medical Letter on Drugs and Therapeutics • August 5, 2013; (Issue 1422)
The FDA has approved two new oral kinase inhibitors for
treatment of unresectable or metastatic melanoma:
dabrafenib (Tafinlar – GSK) for melanomas with BRAF
V600E mutations and trametinib (Mekinist –...
The FDA has approved two new oral kinase inhibitors for
treatment of unresectable or metastatic melanoma:
dabrafenib (Tafinlar – GSK) for melanomas with BRAF
V600E mutations and trametinib (Mekinist – GSK) for
melanomas with either BRAF V600E or V600K mutations.
Dabrafenib is not recommended for patients with
wild-type BRAF (BRAF-negative) melanoma, and trametinib
is not recommended for patients who have
received prior BRAF-inhibitor therapy.