New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study demonstrate that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A mutated or deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma.
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 August 16, 2019, the Food and Drug Administration approved fedratinib (INREBIC®, Impact Biomedicines, Inc.) for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
The Centers for Medicare & Medicaid Services (CMS) released a new national coverage determination (NCD) announcing that Medicare will now cover Food and Drug Administration (FDA)-approved Chimeric Antigen Receptor T-cell (CAR T-cell) therapy for certain patients with cancer.
ASCO recently submitted comments to the Food and Drug Administration (FDA) regarding the agency’s draft guidance recommending specific approaches for sponsors of clinical trials to broaden eligibility criteria, redesign clinical trials, and remove patient barriers to increase enrollment of underrepresented populations in their clinical trials.
Precision medicine treatments (otherwise known as targeted therapies) have the potential to improve outcomes for patients with advanced cancer. Over the last 5 years, 20% of the U.S. Food and Drug Administration’s (FDA) drug approvals have been for precision medicine treatments. With so many treatments coming onto the market, it can be challenging for oncologists to navigate the options available to identify the right treatment for each patient.
On August 2, 2019, the Food and Drug Administration approved pexidartinib (TURALIO™, Daiichi Sankyo) capsules for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Pexidartinib is the first systemic therapy approved for patients with TGCT.
On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA®, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer.
ASCO submitted comments to a Senate Finance Committee markup on the “The Prescription Drug Pricing Reduction Act (PDPRA),” a package of proposals aimed at addressing the high cost of prescription drugs.
The American Society of Clinical Oncology (ASCO) recently received clarification from the United States Pharmacopeia (USP) around the newly revised USP General Chapter <797> Pharmaceutical Compounding Standards – Sterile Preparations and USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings, which become official December 1, 2019 and may not apply to most U.S. oncology practices that administer and prepare oncological agents. However, as rules and regulations vary across states, practices should contact their respective state pharmacy board, medical board, regulatory agency, and/or accrediting organization to determine how the standards may apply to their specific situation.
In early July 2019, 14 out of the 16 members of the House GOP Doctors Caucus sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma requesting that their agencies reconsider a policy allowing Medicare Advantage plans to use step therapy.
On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule to update and streamline the prior authorization process under Medicare Part D. The proposal aims to improve access to prescription medications for Part D beneficiaries and alleviate administrative burden for providers. Under the proposal, clinicians would be able to complete prior authorizations for Part D prescriptions online and through a more streamlined process. ASCO supports efforts to improve the prior authorization process for patients and providers, including electronic prior authorizations.
ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the 2020 Hospital Inpatient Prospective Payment System (IPPS) proposed rule. ASCO’s comments focus on appropriate coverage and reimbursement for Chimeric Antigen Receptor T-Cell Therapy (CAR-T) therapies, the need to address disparities between rural and urban hospitals, and implementation of meaningful quality measures to improve cancer care for patients and providers.
On June 17, 2019, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.