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Issues
2021
February 2021, Vol 12, No 1 | Payers’ Perspectives In Oncology: ASH 2020 Highlights
February 2021, Vol 12, No 1
ASH 2020 Presidential Symposium Highlights Innovations Aimed to Improve Patient Access to Treatment
By
Wayne Kuznar
Value-Based Care
February 2021, Vol 12, No 1
Cellular immunotherapy was featured prominently during ASH 2020, with many presentations detailing deep and durable responses in a range of hematologic malignancies, mostly large B-cell lymphoma.
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Ruxolitinib in Graft-versus-Host Disease: Practice-Changing Results
By
Phoebe Starr
Graft-Versus-Host Disease
February 2021, Vol 12, No 1
In a phase 3 clinical trial, ruxolitinib (Jakafi) led to superior overall response rates and durable responses compared with best available therapy (ie, control group) in patients with steroid-dependent or steroid-refractory chronic graft-versus-host disease (GVHD), with acceptable safety, according to results presented at ASH 2020.
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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 More
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 More
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 More
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.
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First-Line Mosunetuzumab Safe and Effective in Older Patients with Diffuse Large B-Cell Lymphoma
By
Chase Doyle
Emerging Therapies
,
Lymphoma
February 2021, Vol 12, No 1
Single-agent mosunetuzumab is a safe and clinically promising chemotherapy-free therapy for elderly and unfit patients with untreated diffuse large B-cell lymphoma (DLBCL), said Adam J. Olszewski, MD, Associate Professor of Medicine, Brown University, Providence, RI, at ASH 2020. Dr Olszewski reported the results of a phase 1/2 clinical study of mosunetuzumab in patients with DLBCL.
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Asciminib, First-in-Class STAMP Inhibitor, Superior to Bosutinib in Chronic-Phase CML
By
Phoebe Starr
Leukemia
February 2021, Vol 12, No 1
Asciminib, an investigational first-in-class STAMP (specifically targeting the ABL myristoyl pocket) inhibitor, was superior to standard treatment with bosutinib (Bosulif) in patients with chronic-phase chronic myeloid leukemia (CML) who previously received 2 or more tyrosine kinase inhibitors (TKIs) in the phase 3 ASCEMBL clinical trial. The results were presented at a late-breaker session at ASH 2020 by lead investigator Andreas Hochhaus, MD, Director, Department of Hematology and Oncology, Klinik für Innere Medizin II, Jena, Germany.
Read More
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 More
Xpovio Approved for Patients with Relapsed or Refractory Multiple Myeloma
FDA Approvals, News & Updates
,
Multiple Myeloma
February 2021, Vol 12, No 1
On
December 18, 2020
, the FDA approved selinexor (Xpovio; Karyopharm Therapeutics) in combination with bortezomib (Velcade) and dexamethasone for the treatment of adults with multiple myeloma after ≥1 previous therapies. The FDA granted this indication an orphan drug designation.
Read More
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