On September 22, 2017, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.
On September 22, 2017, the Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval was based on a 154-patient subgroup of CHECKMATE-040 (NCT 01658878), a multicenter, open-label trial conducted in patients with HCC and Child-Pugh A cirrhosis who progressed on or were intolerant to sorafenib.
Practices with one active ASCO or American Society for Radiation Oncology (ASTRO) member can use the QOPI® Reporting Registry to report to the Centers for Medicare and Medicaid Services Merit-Based Incentive Payment System.
ASCO submitted comments to the Food and Drug Administration (FDA) in response to a request for feedback on administering the 1984 Hatch-Waxman Amendments, which first established a regulatory pathway for the entry of generic drugs to the marketplace.
During ASCO's Advocacy Summit on September 27 - 28, oncology care providers will be on Capitol Hill to encourage policymakers to support cancer policy priorities that will ensure patients with cancer have access to high-quality, high-value care.
In letters to the Centers for Medicare & Medicaid Services (CMS), ASCO President Bruce E. Johnson, MD, FASCO, comments on provisions in the proposed rules for the 2018 Medicare Physician Fee Schedule (MPFS) and the 2018 Hospital Outpatient Prospective Payment System (HOPPS) that will affect the delivery of oncology care in multiple settings.
Nearly 30 ASCO members from across the country met with their members of Congress and congressional staff during the August 2017 district work period. These meetings provide a unique opportunity for ASCO members to meet directly with lawmakers in order to build stronger relationships and help legislators better understand the realities and challenges of cancer care.
CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO has announced that Southeastern Medical Oncology Center (SMOC) recently signed an agreement to participate in the CancerLinQ® platform, the first oncology practice in Eastern North Carolina to do so.
The U.S. Food & Drug Administration (FDA) and the Oncology Center of Excellence (OCE) will host a complimentary public workshop, Assessment of Cardiovascular Toxicities in Immuno-oncology Trials, on December 1, 2017 at FDA’s White Oak Campus in Silver Spring, MD. ASCO is supporting the workshop with the American College of Cardiology (ACC), the American Heart Association (AHA), and the American Association for Cancer Research (AACR).
On September 14, 2017, the U.S. Food and Drug Administration granted accelerated approval to copanlisib (ALIQOPA™, Bayer HealthCare Pharmaceuticals Inc.) for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Approval was based on efficacy results in 104 patients with relapsed follicular lymphoma enrolled in an open-label, single-arm, multicenter, phase 2 trial. Patients received 0.8 mg/kg or 60 mg of copanlisib by intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle.
On September 14, 2017, the U.S. Food and Drug Administration approved a lower dose of cabazitaxel (20 mg/m2 every 3 weeks) (JEVTANA®, Sanofi-Aventis) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010. The approval was based on data from a noninferiority, multicenter, randomized, open-label trial (PROSELICA) of 1200 patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.
On Sept. 14, 2017, the U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
On September 8, three Spanish Practices received Quality Oncology Practice Initiative (QOPI®) Certification during an ASCO Quality Reception at the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain.
The September 2017 issue of the Journal of Oncology Practice (JOP) is a Special Series on the important role of palliative care in the oncology setting. The issue features research on a variety of aspects of palliative care that address contemporary issues amid its progress in oncology.
The Senate Appropriations Committee included a $2 billion increase for the National Institutes of Health in their Fiscal Year 2018 bill, however Congress voted to pass a three-month Continuing Resolution (CR), which will keep NIH and NCI at flat funding through December 8, 2017.