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TxSCO Newsline

ALUNBRIG (brigatinib) Receives FDA Approval

Takeda Oncology is proud to announce the FDA approval of ALUNBRIGTM (brigatinib), a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Click here to read the complete announcement.
Prescribing information can be found here.

Posted 5/23/2017


Astellas Announces New XTANDI Data from the TERRAIN Trial

Astellas Pharma US, Inc. is pleased to announce new XTANDI data from the TERRAIN trial. The XTANDI Prescribing Information has been updated to reflect results from the TERRAIN trial, a phase 2, randomized, double-blind trial vs bicalutamide in metastatic castration-resistant prostate cancer. Please see the documents below for more information.

New trial data added toXTANDI Prescribing Information
Established efficacy from PREVAIL and new data from TERRAIN

Posted 11/14/2016

Attend a Financial Advocacy Network Case-Based Workshop

The ACCC Financial Advocacy Network (FAN) is a resource designed for professionals who work directly with patients on complex financial issues surrounding their cancer diagnosis and treatment.

FAN is coming to Dallas! Join FAN on August 17 in Dallas, TX for a FREE, one-day, case-based workshop led by professionals in the field. Financial advocacy experts will examine real-world scenarios through peer-to-peer discussion, analysis, and collaborative problem solving.

Click here to view the full agenda or to register. For a full list of resources that support the effective delivery of financial advocacy services in your cancer center, please check out the ACCC FAN Toolkit.

Posted 7/12/2016

FDA Approves Gilotrif for Patients with Squamous Cell Carcinoma of the Lung

Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

The U.S. approval follows the recent marketing authorization of Gilotrif in this patientpopulation by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

Read the corporate press release here.

Posted 4/29/2016

TxSCO Urges CMS to Withdraw Part B Drug Payment Model From Consideration

As many of you know, in early March, CMS proposed a program that would have a detrimental impact on our ability to provide high quality cancer care to our patients. The Medicare Part B Drug Payment Model proposes a sweeping change to Part B reimbursement, and may be implemented as early as this fall.

The state society recently sent a letter on behalf of members to our elected officials to oppose CMS’ ill-conceived proposal.

Posted 4/28/2016

First Call: Fellows Research Competition

The Texas Society of Clinical Oncology (TxSCO) invites you to submit an abstract to participate in our Annual Fellows Research Competition opening June 6, 2016.

All abstracts will be reviewed for presentation during the conference.  Selected authors are invited to attend the meeting and must be present to receive a monetary recognition award. Your submitted abstract should be available for viewing for the duration of the conference.

Fellows receive a one year complimentary TxSCO membership with attendance.

Posted 4/21/2016

FDA Approves Imbruvica for the First-line Treatment of Chronic Lymphocytic Leukemia

On March 4, 2016, the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).

Learn more here.

Posted 4/1/2016

ACCC Expresses Strong Opposition to CMS Proposed Medicare Part B Payment Model Rule

Last week, TxSCO joined with the Association of Community Cancer Centers (ACCC), American Society of Clinical Oncology (ASCO), the Community Oncology Alliance (COA), and approximately 100 other organizations in a letter to HHS Secretary Sylvia Burwell and Acting CMS Administrator Andy Slavitt expressing “strong concern” about the agency’s plans to put forward a proposed rule for the Medicare Part B Drug Payment Model and asking the agency not to proceed with the initiative.

The rule is scheduled to be published in the March 11 Federal Register. Comments on the proposed rule are due by May 9.

Read letter here. Read the ACCC press release here.

Read the CMS proposed rule here. Read CMS fact sheet here.

Posted 3/9/2016

FDA Approves New Indication for Faslodex® (Fulvestrant)

AstraZeneca announced that the FDA has approved a new indication expanding the use of Faslodex®(fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.  

Faslodex has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

Read the full corporate announcement here.

Posted 3/8/2016

A Message From the TxSCO President

As President of the Texas Society of Clinical Oncology (TxSCO) I had the pleasure of leading our annual conference in Austin in September 2015. The TxSCO meeting had representation from virtually all the academic oncology programs, including MD Anderson, Scott & White, UT Southwestern, Baylor, Lubbock, and the military program in San Antonio. Many TxSCO members from community oncology practices across Texas were also in attendance.

I am proud and excited that we had a record number of oncology fellows in training (24) who presented their scientific research findings at our meeting. As we plan the curriculum for our spring Leadership Day in March, and our Annual Membership Conference next September (in Houston), we want to build on the momentum we created with the Texas Fellows entering the specialty of oncology. We will provide more opportunities for them with a career development program.

Here are some highlights of the TxSCO meeting in Austin this past September:

It is a pleasure to be leading the activities of TxSCO, and we hope you join us at the next conference. 

Sincerely,

Ray Page, DO, PhD, FACOI
President, TxSCO

Posted 11/13/2015

FDA Approves Ninlaro in Combination Regimen for Previously Treated Multiple Myeloma Patients

On Nov. 20, 2015, the U.S. Food and Drug Administration (FDA) approved ixazomib (Ninlaro, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor.

Read the FDA announcement here.

Read the FDA press release here.

November 24, 2015

Zarxio (filgrastim-sndz) Launched, First Biosimilar in U.S.

Sandoz, a Novartis company, announced Sept. 3, 2015, that Zarxio (filgrastim-sndz) is now available in the United States. Zarxio, a biosimilar version of Neupogen (filgrastim), was approved by the U.S. Food and Drug Administration in March.

Read the company press release here.

Read the March 6 FDA approval press release here.

Posted 9/9/2015

Apply to ASCO Leadership Development Program

Participants in this year-long leadership program will gain extensive exposure to the roles and mission of ASCO, our Leadership, and the Society's powerful place in developing the future of cancer care, providing both an orientation to ASCO as well as leadership training skills to newer members of the Society. Applicants must have completed their final subspecialty training between 2006 and 2011.

This program requires a time commitment for travel* and training.

Through the Leadership Development Program, participants will:

*Leadership Development Program participants are required to attend all sessions. ASCO will cover the housing and travel costs for participants to attend sessions at ASCO Headquarters. Applicants must be a full member of ASCO between 5 and 10 years post-fellowship training. Applications require one letter of recommendation from an ASCO member, an endorsement letter from your supervisor/senior member, and a brief essay explaining one's desire to be part of the Program.

To learn more about the ASCO's Leadership Development Program or to apply, please visit www.asco.org/leadership.

All applications must be received by September 24, 2015

Posted 8/24/2015

New Clinical Trials Resource

To raise awareness and advance cancer treatment and science, the American Cancer Society and Genentech have teamed up to provide About Clinical Trials (ACT).

ACT is a series of unbiased videos and patient resources. Study participants, clinicians, thought leaders, nurses, and others share their experience in order to educate and inspire patients, caregivers, and physicians to act by considering enrollment in cancer clinical trials. Society Chief Medical Officer Otis W. Brawley, MD, is featured.

Go to LearnAboutClincialTrials.org to learn more about clinical trials and access resources to help patients make educated decisions about their treatment, including the American Cancer Society's Clinical Trials Matching Service. Constituents may also call the American Cancer Society National Call Information Center (NCIC) at 800.227.2345 to receive a free patient kit, which contains an educational brochure with a DVD and USB drive, and also directs inquiries to the Clinical Trials Matching Service.

Posted 8/24/2015

Immuno-Oncology Coverage & Reimbursement Webinar

August 27 at Noon, EST, join Niesha Griffith, RPh, MS, FASHP, Administrator of Oncology Pharmacy and Infusion Services at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University and Bill McGivney, PhD, Principal of McGivney Global Advisers for a complimentary webinar to discuss the intricate coverage and reimbursement issues related to immuno-oncology agents. Brought to you by the Institute for Clinical Immuno-Oncology (ICLIO) An Institute of ACCC.

Discussion will include:
-Determination of coverage and reimbursement for I-O agents
-Compendia review
-Present coverage for I-O agents
-Impact of new Oncology Value Metrics
-Institutional considerations and needs
-Assurance of explicit, timely, and clear coverage policies
-Reimbursement issues in contracting, pilot projects etc.

Click here to register.

Posted 8/14/2015

2015 Fellows’ Research Competition Winners

Fellows

Four oncology fellows are being recognized at the annual TxSCO Membership Conference on September 12, 2015, at The Westin Austin at the Domain.

Divya Arora, MD
Baylor Scott and White/Scott and White Memorial Hospital
Induction chemotherapy with cisplatin-docetaxel followed by concurrent chemoradiation for locally advanced head and neck cancer.

Matthew Gestaut, MD       
Texas A&M University/Scott and White Memorial Hospital
Manipulation of Sphingosine Kinase-2 Mitogenic Signaling in Androgen Therapy Resistant Prostate Cancer.

Arjun Gupta, MD
University of Texas Southwestern Medical Center
Statin use and Mortality in Patients with Colorectal Cancer: A Systematic Review and Meta-Analysis of Observational Studies.

Giancarlo Moscol, MD

University of Texas Southwestern Medical Center – Albert Einstein Medical Center
Correlation of pretreatment surgical staging and PET SUVmax with outcomes in NSCLC.

Posted 8/7/2015

Webinar on Immunotherapy and Advanced Melanoma

ACCC members are invited to join Dr. Michael Postow for an interactive webinar on the role of immunotherapy in treating patients with advanced melanoma. As part of the Principles and Application of Immunotherapy of Cancer series, this free, CME/ANCC/APCE-certified webinar will be held this Friday, May 22, from 7:30 am - 8:30 am ET.  

Topics include:

View the agenda and register for the May 22 webcast today! Please share this webinar with all members of your team who provide care for patients with melanoma.

Your cancer program can host a private webinar on integrating immunotherapy into the treatment of melanoma or lung cancer, at no charge. Email Lorna Lucas or call 866.690.9902 for more information.

Posted 5/20/2015

TxSCO Joins Health Care Payment Learning and Action Network

The Association of Community Cancer Centers (ACCC), on behalf of TxSCO, has joined HHS' Health Care Payment Learning and Action Network, a collaborative network of payers, employers, providers, patients, states, and consumer groups, who will work together to generate knowledge, capture best practices, disseminate information, and apply lessons learned that support the increased adoption of value-based payments in Medicare.

The network was created in tandem with HHS Secretary Burwell's January announcement that set tangible goals to shift Medicare payments towards value-based payments.

Posted 4/3/2015

Opportunity to Host Immunotherapy Webinars

Principles and Application in Immunotherapy of Cancer is a CME/ANCC/ACPE certified education series designed for multidisciplinary oncology care teams. Presented in an interactive webinar format, the series will provide a full overview of the core principles of immunotherapy and a review of issues related to the clinical application of these therapies in Melanoma and Lung Cancer from the convenience of your own office. Cancer practices can choose to participate in one or both of these 60-minute tumor-specific tracks. The series has been developed by a faculty committee composed of 1 physician expert and 1 nurse practitioner along with input from 10 additional presenting faculty.

This private webcast provides your practice with exclusive access. The format is designed so that your team members can learn and connect directly with expert faculty well versed in immunotherapy principles and clinical application. The opportunity is available at no cost to participating practices.

This series is jointly provided by Postgraduate Institute for Medicine and Clinical Care Options, LLC, in partnership with ACCC.

If your cancer practice is interested in participating, or if you would like more information, please contact me at directly at llucas@accc-cancer.org.

Posted 2/3/2015

FDA Approval of Keytruda (pembrolizumab) for Treatment of Unresectable or Metastatic Melanoma

The U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) for the treatment of patients with unresectable melanoma or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Novitas Solutions, Inc. – Coding New Drugs
Novitas addresses coding new drugs in its Medicare JH Local Coverage Article A52018. Not Otherwise Classified (NOC) codes should only be reported for those drugs that do not have a valid HCPCS code. The NOC code is selected based upon the therapeutic value of the drug (e.g., J9999 Prescription drug, oral, chemotherapeutic, NOS; J3490 Unclassified drugs, etc.). The billing requirements for Keytruda are included here. Please also note the Medicare JH New Drug Code Pricing section of the Novitas website.

Posted 1/6/2015


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