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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Tagrisso Approved as Adjuvant Therapy for NSCLC with EGFR Mutations
FDA Approvals, News & Updates
,
Lung Cancer
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved osimertinib (Tagrisso; AstraZeneca) for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) and
EGFR
exon 19 deletions or exon 21
L858R
mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA goal date and granted it a breakthrough therapy designation. Osimertinib was previously approved for the first-line treatment of metastatic NSCLC and
EGFR
exon 19 deletions or exon 21
L858R
mutations, and for the treatment of metastatic NSCLC and
EGFR
T790M mutation after
EGFR
tyrosine kinase inhibitor therapy.
Read Article
Xalkori Approved for Anaplastic Large-Cell Lymphoma and ALK Mutation in Young Patients
FDA Approvals, News & Updates
,
Lymphoma
February 2021, Vol 12, No 1
On
January 14, 2021
, the FDA approved crizotinib (Xalkori; Pfizer) for the treatment of young patients aged 1 to 21 years with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) and
ALK
mutation. The safety and efficacy of crizotinib have not been established in older adults with this diagnosis. The FDA granted this application priority review and breakthrough therapy and orphan drug designations. Crizotinib was previously approved for patients with metastatic non–small-cell lung cancer and
ALK
or
ROS1
mutation.
Read Article
FDA Approves Margenza for Treatment of Metastatic HER2-Positive Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
February 2021, Vol 12, No 1
On
December 16, 2020
, the FDA approved margetuximab-cmkb (Margenza; MacroGenics) in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received ≥2 previous anti-HER2 regimens, of which at least 1 was for metastatic disease. The application for this approval received a fast-track designation.
Read Article
Orgovyx First FDA-Approved Oral Hormone Therapy for Advanced Prostate Cancer
FDA Approvals, News & Updates
,
Prostate Cancer
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved relugolix (Orgovyx; Myovant Sciences), an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of adults with advanced prostate cancer. Relugolix is the first oral androgen-deprivation therapy (ADT) and the first oral GnRH receptor antagonist approved for patients with advanced prostate cancer. The FDA granted relugolix priority review for this indication.
Read Article
FDA Approves Tepmetko for Metastatic NSCLC and MET Exon 14 Skipping Alterations
FDA Approvals, News & Updates
,
Lung Cancer
February 2021, Vol 12, No 1
On
February 3, 2021
, the FDA accelerated the approval of oral tepotinib (Tepmetko; EMD Serono) for adults with metastatic non–small-cell lung cancer (NSCLC) harboring
MET
exon 14 (
MET
ex14) skipping alterations. This approval is for treatment-naïve patients as well as for patients who have received previous therapy. Tepotinib is the second
MET
inhibitor approved by the FDA and should be selected for treatment based on the presence of
MET
ex14. The FDA has granted tepotinib breakthrough therapy and orphan drug designations.
Read Article
FoundationOne CDx Approved as Companion Diagnostic for Vitrakvi to Identify NTRK Fusions in Solid Tumors
FDA Approvals, News & Updates
December 2020, Vol 11, No 6
On
October 23, 2020
, the FDA approved the FoundationOne CDx diagnostic test as a companion diagnostic to identify fusions in the
NTRK1
,
NTRK2
, and
NTRK3
genes in patients who are eligible for treatment with larotrectinib (Vitrakvi).
Read Article
FDA Expands FoundationOne Liquid CDx Indications for Several Mutations in Various Cancers
FDA Approvals, News & Updates
December 2020, Vol 11, No 6
In October and November, the FDA approved FoundationOne Liquid CDx (Foundation Medicine), a next-generation sequencing liquid biopsy test, for the identification of multiple cancers and biomarkers.
Read Article
Opdivo plus Yervoy First Immunotherapy Approved for Unresectable Malignant Pleural Mesothelioma
FDA Approvals, News & Updates
,
Mesothelioma
December 2020, Vol 11, No 6
On
October 2, 2020
, the FDA approved the combination of nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, and ipilimumab (Yervoy; Bristol Myers Squibb), a CTLA-4 inhibitor, for first-line treatment of adults with unresectable malignant pleural mesothelioma.
Read Article
Keytruda Approved for Relapsed or Refractory Classical Hodgkin Lymphoma
FDA Approvals, News & Updates
December 2020, Vol 11, No 6
On
October 14, 2020
, the FDA expanded the approval of pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, for the treatment of relapsed or refractory classical Hodgkin lymphoma in adults and for refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in pediatric patients that has relapsed after receiving ≥2 lines of therapy. The FDA granted pembrolizumab orphan drug and breakthrough therapy designations for this indication.
Read Article
Keytruda plus Chemotherapy Approved for Unresectable or Metastatic Triple‑Negative Breast Cancer
Breast Cancer
,
FDA Approvals, News & Updates
December 2020, Vol 11, No 6
On
November 13, 2020
, the FDA accelerated the approval of pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, plus chemotherapy, for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in patients with PD-L1 (combined positive score [CPS] ≥10), as determined by an FDA-approved test.
Read Article
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Home
Issues
Online First
Latest Issue
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Personalized Medicine
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Conference Correspondent
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