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.
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.
April 29, 2016
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.
April 28, 2016
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.
April 1, 2016
Last week, SCOS 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.
March 9, 2016
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.
March 8, 2016
Important message for South Carolina physicians:
Please take a moment to review the information below from the SC Hospital Association regarding a new requirement for prescribing Schedule II through Schedule IV controlled substances. Click here for an FAQ document that will help to answer some common questions. This new requirement will take effect on April 1, 2016.
From the SCHA CEO/CFO Update:
DHHS TO REQUIRE PROVIDERS TO CONSULT DHEC’S PRESCRIPTION MONITORING PROGRAM.For the past several months, SCHA has been researching efforts underway around the state related to the prevention of opioid abuse. This all began with a report commissioned by the Governor’s Prescription Drug Abuse Prevention Council. The purpose of the Council was to prevent prescription drug abuse and drug diversion and to improve patient safety. One of the Council’s recommendations was to require prescribers to check the South Carolina Reporting and Identification Prescription Tracking System (SCRIPTS) before issuing opioid prescriptions to patients.
Earlier this month, the Medicaid agency issued a bulletin indicating that they will now require providers to verify the controlled substance prescription history of all Medicaid members via SCRIPTS before issuing prescriptions for opioids. The bulletin indicates that failure to consult SCRIPTS could result in loss of Medicaid payments for the office visit. This new requirement will take effect April 1 and will apply to all Schedule II through IV controlled substances. There are a few exceptions cited in the bulletin. For full details, view the bulletin and other details, including how to enroll providers in SCRIPTS, at the DHHS website.
March 7, 2016
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.
November 24, 2015
Effective 10/2/2015, the FDA has approved Keytruda®(Pembrolizumab) at a dose of 2 mg/kg as an intravenous infusion every three weeks for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda®.
October 22, 2015
Boehringer Ingelheim announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition. Click here for the full press release.
August 28, 2015
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.
August 24, 2015
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
-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.
August 14, 2015
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.
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.
May 20, 2015
The Association of Community Cancer Centers (ACCC), on behalf of SCOS, 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.
April 3, 2015
On Feb. 18, 2015, Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma.
Read company press release here.
March 9, 2015
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 email@example.com.
February 3, 2015