The MEDS Act takes important steps toward ending the drug shortage crisis we are experiencing today, ASCO Board of Directors member Peter C. Adamson, MD stated during a briefing on Capitol Hill. Dr. Adamson spoke in support of Senate bill S. 2723, “The Mitigating Emergency Drug Shortages (MEDS) Act,” at the November 5 briefing.
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.
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The U.S. Food and Drug Administration (FDA) recently announced a reorganization and renaming of the office responsible for reviewing applications for new and existing cancer therapies.
The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been renamed the Office of Oncologic Diseases (OOD). Richard Pazdur, MD, will serve as the acting director of OOD and continue his role as director of the FDA Oncology Center of Excellence (OCE).
Norman “Ned” Sharpless, MD, returned to his post of Director of the National Cancer Institute (NCI) earlier this month. Dr. Sharpless had been serving as Acting Commissioner of the Food and Drug Administration (FDA) since Dr. Scott Gottlieb stepped down in April 2019.
Earlier this month, President Trump announced his nomination of Dr. Stephen Hahn to serve as the new Commissioner of the FDA. Admiral Brett Giroir, MD, will serve as Acting Commissioner of the FDA until a permanent commissioner is confirmed by the Senate.
ASCO developed a Decision Aid to assist physician-investigators and research staff in determining whether an AE should be reported to the sponsor as an SAE and attributed to the investigational drug.
On September 26, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).
On September 17, 2019, the Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (KEYTRUDA®, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
On September 17, 2019, the Food and Drug Administration approved apalutamide (ERLEADA®, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer.
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).
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.
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.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recently expanded its HPV vaccination age range recommendations. These expansions include catch-up vaccinations for persons through age 26 who are not adequately vaccinated, and recommended vaccination based on shared clinical decision making for individuals ages 27 through 45 years who are not adequately vaccinated.
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.
A recent American Medical Association (AMA) report on opioids highlights how provider mandates—on training, prior authorizations—have not had a significant impact on curtailing the opioid epidemic. According to the Opioid Task Force 2019 Progress Report, prescription opioid-related mortality may be leveling off, however deaths from heroin and illicitly manufactured fentanyl and fentanyl analogs are at an all-time high. Instead, the report calls on policymakers to address the opioid epidemic with policies to promote evidence-based treatment.