February 20, 2018
On September 16, 2018, the U.S. Food and Drug Administration (FDA) approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).
.
February 14, 2018
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.
The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program , an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page . Read FDA press release .
Posted 2/14/2018
February 14, 2018
On February 14, 2018, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) jointly announced release of guidance on managing side effects of immunotherapy with immune checkpoint inhibitors. The organizations note that these guidelines pertain only to immune checkpoint inhibitors, not to other types of immunotherapy.
To date, several checkpoint inhibitor immunotherapies have been approved by the U.S. Food and Drug Administration (FDA) for treatment of a number of cancer types, including melanoma, Hodgkin lymphoma, and lung, liver, kidney, and bladder cancer. In the rapidly evolving cancer immunotherapy landscape, the number of agents, new indications, and combination therapies continues to grow.
In a joint news release, ASCO and NCCN briefly outline the guideline development process, which included convening multidisciplinary panels with representation from medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, and nursing, as well as patient advocacy experts. The clinical recommendations were based on a systematic literature review and an informal consensus process.
"The Management of Immune-related Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline," was published online February 14, 2018, in the Journal of Clinical Oncology. Read the article .
NCCN Guidelines® for Management of Immunotherapy-Related Toxicities were published online at NCCN.org on February 14, 2018.
ASCO and NCCN welcome feedback on their guidelines from oncologists, practitioners, and patients through the ASCO Guidelines Wiki or via the NCCN submission form at NCCN.org .
February 12, 2018
The National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine (NASEM) has announced that the final Proceedings from its public workshop , Incorporating Weight Management and Physical Activity Throughout the Cancer Care Continuum are now available.
The workshop, held February 13-14, 2017, in Washington, D.C., highlighted the current evidence base, gaps in knowledge, and research needs on the associations among obesity, physical activity, weight management, and health outcomes for cancer survivors. Presentations and discussions also examined the effectiveness of interventions for promoting physical activity and weight management among people living with or beyond cancer, as well as opportunities and challenges for providing weight management and physical activity interventions to cancer survivors. Download proceedings .
Posted 2/12/18
February 12, 2018
A report from the White House Council of Economic Advisors released on February 9 asserts the need for major policy changes at the federal level in order to lower drug prices, including reforms impacting the FDA and changes to Medicare and Medicaid.
Read " Reforming Biopharmaceutical Pricing at Home and Abroad ."
Posted 2/12/2018
February 9, 2018
The Centers for Medicare & Medicaid Services (CMS) is hosting three “Office Hours” sessions on Merit-based Incentive Payment Systems (MIPS) submission over the next several weeks. CMS subject matter experts will answer commonly asked questions about the submission feature on qpp.cms.gov , and answer attendees’ questions live. Registrants will also be able to submit questions by email prior to the sessions.
View “Office Hours” topics and register below. Please note that Qualified Registries, Qualified Clinical Data Registries and Web Interface Reporters should use their support calls for data submission support.
February 14, 3:30-4:30 pm ET
Quality Payment Program Data Submission Office Hours: Individual Eligible Clinician and Group Submission
February 28, 3-4 pm ET
Quality Payment Program Data Submission Office Hours: MIPS Quality Data Submission
March 14, 3-4 pm ET
Quality Payment Program Data Submission Office Hours: MIPS Attestation for Advancing Care Information and Improvement Activities
Space for these sessions is limited. Register now to secure your spot. The audio portion of the sessions will be broadcast through the web. You can listen to the presentation through your computer speakers.
For More Information
For step-by-step instructions on how to submit MIPS data, check out this video and fact sheet . Questions about your participation status or MIPS data submission? Contact the Quality Payment Program Service Center by
email: qpp@cms.hhs.gov .
February 8, 2018
Planning to submit data for the 2017 Merit-based Incentive Payment System (MIPS) Merit-based Incentive Payment System (MIPS) performance period? Deadlines are coming in March, and the Centers for Medicare & Medicaid Services (CMS) urges providers not to wait until the last minute to submit data.
The two key dates are:
If you’re not sure if you are required to report for MIPS, enter your National Provider Identifier (NPI) in the MIPS Lookup Tool to find out whether you need to report. Additionally, if you know you are in a MIPS APM or Advanced APM, you can use the APM Lookup Tool .
Questions about your participation status or MIPS data submission? Contact the Quality Payment Program Service Center by:
For more information and a quality reporting timeline, visit the Quality Payment Program website
Posted 2/8/18
February 8, 2018
The Janssen Pharmaceutical Companies of Johnson & Johnson on February 8, 2018, announced U.S. Food and Drug Administration (FDA) approval of a new indication for Zytiga (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).
Read Corporate Press Release
Posted 2/8/18
February 8, 2018
The American Society of Clinical Oncology (ASCO) reviews six leading commercial oncology pathway vendors in "Oncology Clinical Pathways: Charting the Landscape of Pathway Providers." The article, published online February 7, 2018, in the Journal of Oncology Practice, " assesses six commercial clinical pathway vendors using ASCO's criteria for high-quality clinical pathways.
Read ASCO Press Release Access Article and Learn More
Posted 2/8/18
January 26, 2018
On Jan. 26, 2018, the U.S. Food and Drug Administration (FDA) approved Lutathera (lutetium Lu 177 dotatate) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a type of cancer that affects the pancreas or gastrointestinal tract. This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.
GEP-NETs can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately one out of 27,000 people are diagnosed with GEP-NETs per year.
Posted 1/26/2018
January 25, 2018
On January 24, the U.S. Senate confirmed Alex Azar, as Secretary of the Department of Health and Human Services (HHS) by a 55-43 vote. Azar, a former Eli Lilly executive, is anticipated to align closely with Trump administration policies on the Affordable Care Act, Medicare spending, and other issues, reports Bloomberg BNA.
Posted 1/25/2018
January 25, 2018
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced the much-anticipated release of their updated guideline for molecular testing and targeted therapies in lung cancer. The work of these three leading medical societies, updates their 2013 evidence-based guidelines.
Published first online on January 23, the “ Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors ,” makes revisions to standards for the molecular analysis of lung cancers for test results that reflect advances in understanding of lung cancer and the increase in available molecularly-targeted therapies.
“Several factors influenced this update, which builds on the guidance we set forth in 2013,” said Neal Lindeman, MD, director of Molecular Diagnostics at Brigham and Women’s Hospital and Associate Professor of Pathology at Harvard Medical School in Boston, and AMP member. “Clinical practice guidelines must continually assess new evidence as it accumulates and consider new testing technologies as they emerge,” he said in a statement.
According to the IASLC press release , the updated guideline "strengthens or reaffirms" the majority of recommendations included in the 2013 guideline and recommends testing for some new genes.
View resources from CAP , IASLC , and AMP to help pathologists and oncologists review and implement the guidelines (includes a summary of recommendations, teaching presention, and FAQs).
Posted 1/25/2018
January 22, 2018
The Centers for Medicare & Medicaid Services (CMS) has stated that "During the time that the partial government shutdown is in effect, Medicare Administrative Contractors will continue to perform all functions related to Medicare fee-for-service claims processing and payment." This announcement was made through a special edition of CMS's MLN Connects dated Monday, January 22, 2018.
Posted 1/22/2018
January 19, 2018
The Medicare Payment Advisory Commission (MedPAC) voted on Jan. 11, to recommend to Congress that the Merit-based Incentive Payment System (MIPS) be scrapped. The federal advisory panel suggested replacing the quality reporting program with a Voluntary Value Program. MedPAC is an independent congressional agency established by the Balanced Budget Act of 1997 to advise the U.S. Congress on issues affecting the Medicare program.
Whether Congress will accept MedPAC's recommendation to eliminate MIPS is unknown. However, Bloomberg BNA reports that a House Energy and Commerce Committee spokesperson has indicated that the committee plans to continue work to ensure the success of MIPS.
Posted 1/19/2018
January 12, 2018
On Jan. 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.
This is the first FDA-approved treatment for patients with gBRCAm HER2-negative metastatic breast cancer. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib .
Posted 1/12/2018
January 12, 2018
On Jan. 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Posted 1/12/2018
January 10, 2018
he Association of Cancer Care Centers (ACCC) is deeply saddened by the passing of Marsha Fountain Woznuck, RN, MSN, on January 7, 2018. An active ACCC member for many years, she served on the ACCC Program Committee Advisory Panel (2012-2015); shared her knowledge on ACCCExchange, the association’s member listserv; and presented at ACCC and oncology state society conferences.
Marsha Fountain Woznuck began her career in the cancer field as a pediatric oncology nurse and later transitioned to cancer center administration. She served as vice president for an architecture and design firm focused on patient-centered spaces and as president of a nationally recognized cancer consulting firm.
Her expertise, commitment, and contributions to advancing the care and well-being of patients with cancer will be greatly missed.
Posted 1/10/2018
January 5, 2018
On Jan. 5, 2018, Amgen announced that U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Read the corporate press release .
Posted 1/10/2018
January 3, 2018
The College of American Pathologists (CAP) released its newest evidence-based practice guideline, " Human Papillomavirus (HPV) Testing in Head and Neck Carcinomas ," on December 19, 2017.
The guideline, which recommends accurate assessment of a patient's high-risk HPV status, directly or by surrogate markers, was developed by an interdisciplinary, expert panel that included pathologists, surgeons, radiation oncologists, medical oncologists, patients, and patient advocates.
Based on a screening of 2,200 peer-reviewed articles and a review of evidence from 492 studies, the panel issued 14 final recommendations in the guideline.
Learn more on the CAP website .
Posted 1/3/2018
January 2, 2018
On December 22, 2017, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna, Novartis Pharmaceuticals Corp.) to include information on nilotinib discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5).
Patients with newly diagnosed Ph+ CML in the chronic phase (CP) and resistant or intolerant Ph+ CML-CP patients who have achieved a sustained molecular response (MR4.5) may be considered for discontinuation after at least three years of nilotinib. To be considered for discontinuation, patients must have typical BCR-ABL transcripts. An FDA-authorized test with a detection limit below at least MR4.5 must be used to determine discontinuation eligibility. Patients must be frequently monitored by this test to detect possible loss of remission.
Common adverse reactions in patients who discontinued nilotinib include musculoskeletal symptoms including body aches, bone pain, and extremity pain. Some patients experienced prolonged musculoskeletal symptoms. The long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time.
Posted 1/2/2018