On April 18, 2018, the Food and Drug Administration approved osimertinib (Tagrisso®, AstraZeneca Pharmaceuticals LP) 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.
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.
Melissa Dillmon, MD, chair of ASCO’s State Affiliate Council, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to examine current cancer-related policies that state lawmakers are considering and discuss how ASCO members can get involved. During the podcast, Dr. Dillmon, a hematologist at the Harbin Clinic in Rome, Georgia, highlights a number of state-level issues that will directly impact the cancer care delivery system
ASCO has developed a summary of the key provisions and changes in the updated Common Rule, which protects human participants in biomedical research.
On April 17, 2018, the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE™, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
National Prescription Drug Take Back Day—April 28, 2018— is a nationwide event to educate the public on the safe storage and disposal of drugs and to help patients safely, conveniently, and responsibly dispose of unused or expired opioids and other prescription medications throughout the year. On Take Back Day, patients can visit collection sites near them to turn in medications.
Last month, the Food and Drug Administration (FDA) held a listening session where stakeholders, including ASCO’s Chief Medical Officer, Richard L. Schilsky, MD, FACP, FSCT, FASCO, offered brief comments on role of the Oncology Center of Excellence (OCE).
On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo® and Yervoy®, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
Members of ASCO's Leadership Development Program held a Hill Day to advocate for federal research funding, oral parity, step therapy, and other cancer policy priorities.
ASCO submitted a budget request to a House Committee on Appropriations subcommittee, asking for $3.32 billion in funding for the Food and Drug Administration (FDA) and support for the Administration’s request of $20 million for FDA’s Oncology Center of Excellence (OCE) in Fiscal Year (FY) 2019.
Clinicians can now use the updated Participation Lookup Tool from the Centers for Medicare & Medicaid Services (CMS) to check their 2018 eligibility for the Merit-Based Incentive Payment System (MIPS) under the Quality Payment Program (QPP). Within the online tool, clinicians can enter their National Provider Identifier (NPI) to find out whether or not they need to participate in MIPS during the 2018 performance year.
Nominated by ASCO, as part of its ongoing commitment to ensure the success of its members in Quality Payment Program implementation and participation, eight ASCO volunteers have been chosen to serve on the Centers for Medicare and Medicaid Services (CMS) Oncology Clinical Subcommittee that will provide input on the development of episode-based cost measures for potential use in the Quality Payment Program.
On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma
On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Applications for the Alexandria, Va. session of ASCO’s Quality Training Program, being held at ASCO headquarters, are being accepted now through June 4.
President Trump recently announced that his Administration is developing a “three-pronged plan” to help combat the opioid epidemic in the United States. The announcement comes after the Food and Drug Administration’s (FDA) Opioid Policy Steering Committee released a notice earlier this year requesting comments on several questions related to opioid prescribing, provider education, and prescription drug monitoring programs. ASCO recently submitted extensive comments to the steering committee addressing these questions and reiterating the importance of special consideration of the cancer patient population.