FDA Issues EAU for Monoclonal Antibody to Treat COVID-19

• Have positive results of direct SARS-CoV-2 viral testing
• Are 12-years-old or older
• Weigh at least 40 kilograms (about 88 pounds)
• Are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab has shown through clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment, compared to placebo. As part of the EUA, efficacy of the agent continues to be evaluated and several quality measures have been imposed to protect patients. 

Read the FDA announcement. 

Posted 11/20/2020

FDA Approves Pembrolizumab + Chemotherapy for TNBC

Registration Open: Jakafi (ruxolitinib) Product Theater

Intervening With Jakafi^® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

Jakafi^® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi^® (ruxolitinib) in treating your patients. 

Monday, November 30
12:00 - 1:00 PM EST

Presented by:
Solomon Hamburg, MD, PhD
Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
UCLA Beverly Hills Hematology Oncology
REGISTER

Monday, November 30
3:00 - 4:00 PM EST

Presented by:
Jonathan Abbas, MD
Director, Acute Leukemia Program
Tennessee Oncology
REGISTER

FDA Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC

On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo^®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

The target action date for the FDA decision is February 28, 2021.

Read press release. 

Posted on 10/29/2020.

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

myBeiGene Patient Support for Zanubrutinib

Zanubrutinib (Brukinsa™, BeiGene) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For prescribing information click here, or here for the Dosing and Administration Guide. 

To help guide and assist patients during treatment, Beigene has developed a customized and comprehensive support program. The myBeiGene Patient Support program is staffed with nurses who have prior experience working with oncology patients. Practices and their patients get a dedicated Oncology Nurse Advocate assigned to them, and comprehensive patient support, including connecting patients to helpful resources that can address their personal needs.

Posted on 10/07/2020

Exelixis Access Services® EASE

Exelixis Access Services^® (EASE) provides a variety of support to help your patients get started on cabozantinib (Cabometyx^®)as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey. 

Posted 10/02/2020

Cabozantinib Prescribing Information and Resources

Exelixis has issued prescribing information for cabozantinib (Cabometyx^®), which is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib as well as a series of resources that you can utilize in your practice. 

Access Prescribing Information and Resources.

Posted 10/02/2020

FDA Approves Nivolumab + Ipilimumab Immunotherapy Treatment for Mesothelioma

On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.

Read the FDA Announcement.

Read the Bristol Myers Squibb Announcement.

Posted 10/5/2020 

FDA Approves Two Liquid Biopsy Companion Diagnostics for Osimertinib

On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne^® Liquid CDx and Guardant360^® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso^®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

See full prescribing information.

About FoundationOne^® Liquid CDx.

About Guardant360^® CDx.

Posted 9/24/2020