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Trazimera Fourth Biosimilar to Herceptin Approved for HER2-Positive Breast Cancer or HER2-Positive Metastatic Gastric or Gastroesophageal Junction Cancer
Breast Cancer
,
FDA Approvals, News & Updates
,
Biosimilars
April 2019, Vol 10, No 2
On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin.
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Strategic Insights on Midsize Employers and Cancer Care Coverage
By
Bincy Augustine, PharmD
;
F. Randy Vogenberg, PhD, RPh, FASHP
Employers’ Perspective
,
Value Peer-spectives
April 2019, Vol 10, No 2
It is no surprise that healthcare costs are at an all-time high and continue to take center stage in political, social, and economic debates. Employers, as health plan sponsors and as purchasers of care, are looking to take matters into their own hands and tackle the problem through innovative reimbursement strategies. Not all employers, however, are built the same. Experiences in controlling healthcare costs vary between small and large employers. The most affected employers are in the middle and are known as midsize employers.
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SM-88, a Novel Tumor Metabolism–Altering Regimen, Shows Promise as Third-Line Therapy for Metastatic Pancreatic Cancer
By
Wayne Kuznar
GI Cancers Symposium
April 2019, Vol 10, No 2
San Francisco, CA—Increased understanding of tumor genetics and tumor metabolism has led to improved therapies for cancer. The impact of cancer metabolism on tumor pathways is particularly important in pancreatic cancer. A novel tumor metabolism–altering oral drug known as SM-88 combines the investigative tyrosine derivative (D,L-alpha-metyrosine) with 3 repurposed agents—an mTOR inhibitor (sirolimus), a CYP3A4 inducer (phenytoin), and an oxidative stress catalyst (methoxsalen).
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Triple-Drug Regimen Improves Survival in Metastatic Colorectal Cancer with BRAF V600E Mutation
By
Wayne Kuznar
GI Cancers Symposium
April 2019, Vol 10, No 2
San Francisco, CA—Updated results from the safety lead-in of the phase 3 BEACON CRC clinical trial show a mature median overall survival (OS) of 15.3 months with the triple-drug regimen of encorafenib (Braftovi), a BRAF inhibitor; binimetinib (Mektovi), a MEK inhibitor; and cetuximab (Erbitux), an EGFR inhibitor, for the treatment of patients with metastatic colorectal cancer (CRC) and
BRAF
V600E mutation.
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Pembrolizumab a Promising Second-Line Option in PD-L1 Expressing Advanced Esophageal Cancer
GI Cancers Symposium
April 2019, Vol 10, No 2
San Francisco, CA—Pembrolizumab (Keytruda) as a second-line therapy improved overall survival (OS) in patients with advanced or metastatic esophageal cancer and high PD-L1 expression compared with chemotherapy, according to findings from the phase 3 KEYNOTE-181 study presented at the 2019 Gastrointestinal Cancers Symposium.
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Adjuvant Therapy with Durvalumab Shows Promise in Advanced Esophageal Cancer
By
Wayne Kuznar
GI Cancers Symposium
April 2019, Vol 10, No 2
San Francisco, CA—Adjuvant treatment with durvalumab (Imfinzi), a checkpoint inhibitor, in patients with residual disease after trimodal therapy for advanced esophageal or gastroesophageal junction (GEJ) adenocarcinoma was associated with a 79% 1-year relapse-free survival rate in a phase 2 clinical trial. Historically, the 1-year relapse rate has been 50% in patients with GEJ carcinoma who do not achieve a pathologic complete response with trimodal therapy, even with additional chemotherapy, said Hirva Mamdani, MD, Thoracic Oncology, Karmanos Cancer Institute/Wayne State University, Detroit, MI, at the 2019 Gastrointestinal Cancers Symposium.
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CAR T-Cell Therapy Associated with Unique, Acute Adverse Events Requiring Vigilant Monitoring
By
Wayne Kuznar
Immunotherapy
,
Personalized Medicine
April 2019, Vol 10, No 2
San Francisco, CA—Chimeric antigen receptor (CAR) T-cell therapy is associated with unique adverse events that require vigilant monitoring, aggressive care, and specialized management. Marco L. Davila, MD, PhD, Medical Oncologist, Blood and Marrow Transplant and Cellular Immunotherapy Program, Moffitt Cancer Center, Tampa, FL, provided an overview of this topic at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium.
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Genomic Markers of Response Improve Patient Selection for Immune Checkpoint Inhibitor Therapy
By
Wayne Kuznar
Immunotherapy
,
Personalized Medicine
April 2019, Vol 10, No 2
San Francisco, CA—Promising markers of response to immune checkpoint inhibition include tumor mutation burden (TMB) and genomic markers that reflect a disruption of the tumor immunity cycle, said Natalie Vokes, MD, MPhil, Medical Oncology Fellow, Dana-Farber Cancer Institute, Boston, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium.
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Adjuvant Chemotherapy May Be Spared in Localized Breast Cancer If pCR Is Attained with Neoadjuvant Chemotherapy
By
Phoebe Starr
Breast Cancer
April 2019, Vol 10, No 2
San Antonio, TX—Reaching pathologic complete response (pCR) after neoadjuvant chemotherapy correlates with significantly improved event-free survival (EFS) and overall survival (OS) in patients with localized breast cancer, according to results of a large comprehensive meta-analysis presented at the 2018 San Antonio Breast Cancer Symposium.
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Tamoxifen 5 mg Daily as Effective as 20 mg in Early Localized Breast Cancer
By
Phoebe Starr
Breast Cancer
April 2019, Vol 10, No 2
San Antonio, TX—The large, randomized TAM-01 clinical trial demonstrated that 5 mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo.
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Home
Issues
Online First
Latest Issue
Issue Archive
Special Issues
Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
COVID-19
Cholangiocarcinoma
View All Topics ›
Conference Correspondent
ESMO 2025 - Wrap-Up: Triple-Negative Breast Cancer
ASCO 2025 - Wrap-Up: Triple-Negative Breast Cancer
Web Exclusives
Web Exclusive Articles
Videos
Interview with the Innovators
Prostate Cancer Diagnostics Monthly Minutes
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Press Releases
Association for Value-Based Cancer Care
VBCM
Value-Based Care in Myeloma