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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Vidaza Now Approved for Patients with Newly Diagnosed Juvenile Myelomonocytic Leukemia
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On May 20, 2022, the FDA accelerated the approval of a new indication for azacitidine injection (Vidaza; Celgene) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
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Tibsovo Receives a New Indication, in Combination with Vidaza, for Newly Diagnosed Patients with AML and IDH1 Mutation
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On May 25, 2022, the FDA accelerated the approval of ivosidenib tablets (Tibsovo; Servier Pharmaceuticals), in combination with azacitidine tablets (Onureg; Celgene) for newly diagnosed acute myeloid leukemia (AML) and a susceptible
IDH1
mutation, as detected by an FDA-approved test, in patients aged ≥75 years, or patients with comorbidities that preclude the use of intensive induction chemotherapy.
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Kymriah Receives Accelerated FDA Approval for Relapsed or Refractory Follicular Lymphoma
FDA Approvals, News & Updates
June 2022, Vol 13, No 3
On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy.
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Opdivo plus Chemotherapy FDA Approved as First Neoadjuvant Treatment in Early-Stage NSCLC
FDA Approvals, News & Updates
April 2022, Vol 13, No 2
On
March 4, 2022
, the FDA accelerated the approval of the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb) in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of adults with resectable non–small-cell lung cancer (NSCLC). This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC.
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Opdualag, a Novel Immunotherapy Combination, FDA Approved for Advanced Melanoma
FDA Approvals, News & Updates
April 2022, Vol 13, No 2
On
March 18, 2022
, the FDA approved the combination of 2 distinct immune checkpoint inhibitors, the new LAG-3 antibody relatlimab-rmbw (Opdualag; Bristol Myers Squibb) plus the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), for patients aged ≥12 years with unresectable or metastatic melanoma.
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FDA Approves Vonjo for Treatment of Patients with Myelofibrosis and Thrombocytopenia
FDA Approvals, News & Updates
April 2022, Vol 13, No 2
On
February 28, 2022
, the FDA accelerated the approval of pacritinib (Vonjo; CTI BioPharma), a kinase inhibitor, for the treatment of adult patients with intermediate- or high-risk primary or secondary (postpolycythemia vera or postessential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
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Kimmtrak, a Bispecific CD3 T-Cell Engager, First FDA-Approved Drug for Unresectable or Metastatic Uveal Melanoma
FDA Approvals, News & Updates
April 2022, Vol 13, No 2
On
January 25, 2022
, the FDA accelerated the approval of tebentafusp-tebn (Kimmtrak; Immunocore), a bispecific gp100 peptide-HLA–directed CD3 T-cell engager, for the treatment of adult patients with HLA-A*02:01 unresectable or metastatic uveal (intraocular) melanoma.
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Keytruda Monotherapy FDA Approved for Endometrial Carcinoma with a Biomarker
FDA Approvals, News & Updates
April 2022, Vol 13, No 2
On
March 21, 2022
, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) as monotherapy for advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, in patients whose disease progressed after previous systemic therapy in any setting and who are not candidates for curative surgery or radiation.
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Lynparza Receives FDA Approval for Adjuvant Treatment of High-Risk Early Breast Cancer
FDA Approvals, News & Updates
April 2022, Vol 13, No 2
On
March 11, 2022
, the FDA accelerated the approval of the oral PARP inhibitor olaparib (Lynparza; AstraZeneca) for the adjuvant treatment of adults with
HER2
-negative, high-risk early breast cancer and deleterious or suspected deleterious germline
BRCA
mutation after neoadjuvant or adjuvant chemotherapy. Patients must be selected for olaparib therapy for this indication based on an FDA-approved test.
Read Article
Verzenio plus Endocrine Therapy Approved for HR-Positive, HER2-Negative, Early-Stage Breast Cancer
FDA Approvals, News & Updates
December 2021, Vol 12, No 6
On October 12, 2021, the FDA approved a new indication for the cyclin-dependent kinase 4/6 inhibitor abemaciclib (Verzenio; Eli Lilly), in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy, for the treatment of adult patients with hormone receptor-positive,
HER2
-negative, node-positive, early breast cancer at high risk for recurrence, and a Ki-67 score ≥20%, as determined by an FDA-approved test.
Read Article
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Home
Issues
Online First
Latest Issue
Issue Archive
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Personalized Medicine
Economics & Value
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SABCS 2023 - HER2+ MBC
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