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Issues
2017
December 2017, Vol 8, No 5
Online First
The following
Value-Based Cancer Care
articles are now available online ahead of print.
Online First
The NCCN Evidence Blocks and Clinical Practice Guidelines: Identifying Truth
By
Al B. Benson III, MD
;
Robert W. Carlson, MD
March 2016, Vol 7, No 2
A recently published perspective in
Value-Based Cancer Care
criticized the National Comprehensive Cancer Network (NCCN) Evidence Blocks initiative. Regrettably, that perspective is extremely misleading and is full of innuendo and misuse of statistics.
Read Article
Online First
Alecensa a New First-Line Treatment for NSCLC with ALK Mutation
FDA Approvals, News & Updates
December 2017, Vol 8, No 5
On
November 6, 2017
, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with
ALK
mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and
ALK
mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori).
Read Article
Online First
Calquence New Treatment Approved for Mantle-Cell Lymphoma
FDA Approvals, News & Updates
December 2017, Vol 8, No 5
On
October 31, 2017
, the FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for the treatment of adults with mantle-cell lymphoma (MCL) who have received at least 1 previous therapy. The FDA granted acalabrutinib priority review and breakthrough therapy and orphan drug designations for this indication.
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Online First
Verzenio a New CDK4/CDK6 Inhibitor Approved for Metastatic Breast Cancer
FDA Approvals, News & Updates
December 2017, Vol 8, No 5
On
September 28, 2017
, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting.
Read Article
Online First
Yescarta Second Gene Therapy Approved by FDA and First CAR T-Cell Therapy for Large B-Cell Lymphoma
FDA Approvals, News & Updates
December 2017, Vol 8, No 5
On
October 18, 2017
, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma.
Read Article
Online First
Aliqopa the Newest Treatment Approved for Adults with Relapsed Follicular Lymphoma
FDA Approvals, News & Updates
December 2017, Vol 8, No 5
On
September 14, 2017
, the FDA granted accelerated approval to copanlisib (Aliqopa; Bayer Healthcare) for the treatment of adults with relapsed follicular lymphoma who have received ≥2 previous systemic therapies. Copanlisib received priority review and an orphan drug designation for this indication.
Read Article
Online First
Opdivo First Immunotherapy Approved for Hepatocellular Carcinoma
FDA Approvals, News & Updates
December 2017, Vol 8, No 5
On
September 22, 2017
, the FDA granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of hepatocellular carcinoma (HCC)—the most common type of liver cancer—in patients who previously received sorafenib treatment. Opdivo received priority review for this indication.
Read Article
Online First
Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies
FDA Approvals, News & Updates
,
Biosimilars
December 2018, Vol 9, No 4
On November 2, 2018, the FDA approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences), as the second biosimilar to pegfilgrastim (Neulasta), to reduce the risk for infection in patients with nonmyeloid malignancies who receive myelosuppressive chemotherapy, which may result in febrile neutropenia.
Read Article
Online First
Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations
Breast Cancer
,
FDA Approvals, News & Updates
,
Solid Tumors
December 2018, Vol 9, No 4
On October 16, 2018, the FDA approved talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with HER2-negative, locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline
BRCA
mutation, as identified by an FDA-approved test.
Read Article
Online First
Value-Based Care Management Medicare Program Changes for 2020 and Beyond
By
Joseph S. Bailes, MD
;
Gena Cook
Economics & Value
,
Value-Based Care
December 2019, Vol 10, No 6
Medicare models for value-based care in oncology started with the Oncology Care Model (OCM), which was launched in July 2016 and will run until June 2021.
Read Article
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Home
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Personalized Medicine
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SABCS 2023 - HER2+ MBC
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