Policy plays a critical role in the fight against cancer, influencing the funding of cancer research and driving the approval of safe and effective anticancer therapies. With the increasing complexity of cancer-related policy issues, the need for active engagement of cancer researchers in the policymaking process has never been greater.Read More
During late spring and early summer, the U.S. Food and Drug Administration (FDA) approved four new molecularly targeted therapeutics—alpelisib (Piqray), polatuzumab vedotin-piiq (Polivy), selinexor (Xpovio), and darolutamide (Nubeqa)—for treating certain patients with a wide array of cancer types. Molecularly targeted therapeutics are the cornerstone of precision oncology. So, this flurry of approvals highlights that progress in this important area of cancer care is continuing unabated.Read More
Building on advances in technology and analytical tools, real-world data (RWD) sources have attracted increasing interest as means to efficiently answer important clinical, research, and regulatory questions around oncology treatments and outcomes. RWD can come from a variety of sources, including medical claims data, electronic health records, patient-reported outcomes, and product or disease registry data. Real-world evidence (RWE) is clinical evidence generated from these data.
While the randomized controlled trial remains the gold standard for gathering clinical evidence for regulatory use, RWE can provide critical insights in situations where such trials may be difficult to complete. This is especially relevant in oncology, where personalized medicine approaches are leading to increasingly smaller patient populations that necessitate new strategies for efficient drug development.Read More
Every two minutes, a woman somewhere in the world dies of cervical cancer.
That harrowing statistic, shared by Anna R. Giuliano, PhD, founding director of the Center for Immunization and Infection Research in Cancer at the Moffitt Cancer Center in Tampa, Florida, reflects a great frustration in public health. There is a vaccine that prevents infection with the virus that can cause cervical cancer and several other cancer types, yet worldwide, not enough people are taking advantage of it.Read More
In the past year, the number of American teenagers using tobacco products has increased by nearly 40 percent, reversing a trend that public health officials worked tirelessly to achieve.
The primary culprit in the resurgence of smoking? E-cigarettes. Taking aim at this growing public health problem, the American Association for Cancer Research (AACR) held a congressional briefing on Wednesday, June 12, titled “E-cigarettes and Nicotine Addiction: A Potential Health Crisis for Youth and Young Adults.” The roster of speakers included leaders from government, research, and policy sectors.
The tobacco product landscape is evolving and the AACR Tobacco Products and Cancer Subcommittee has been cognizant of the shift from combusted products (e.g., cigarettes) to alternative nicotine delivery systems, such as e-cigarettes. While it is generally accepted that e-cigarettes are safer than traditional cigarettes, these products still present risks and the AACR has been active in trying to keep children from having access to them.Read More
During late March and early April, the U.S. Food and Drug Administration (FDA) made several decisions that have increased the number of treatment options for certain patients with bladder, lung, and kidney cancer. On March 18, 2019, the agency approved the immunotherapeutic atezolizumab (Tecentriq) for treating certain patients with small-cell lung cancer (SCLC). On April 12, 2019, it approved a new molecularly targeted therapeutic—erdafitinib (Balversa)—for treating certain patients with bladder cancer. Then, on April 19, 2019, it approved the immunotherapeutic pembrolizumab (Keytruda) for treating certain patients with kidney cancer.Read More
Therapeutics that target two proteins called cyclin-dependent kinase 4 (CDK4) and CDK6 have revolutionized treatment for breast cancer, Richard S. Finn, MD, told attendees of the Making Science Count for Patients: CDK4/6 special session during the recent AACR Annual Meeting 2019. This session was designed to review the progress made with this class of anticancer therapeutics, starting from basic science through preclinical and clinical development, and to look to what we might expect from these agents in the future.Read More
Although checkpoint inhibitors and other immunotherapies are remarkably effective for patients with some cancers, demonstrating durable antitumor activity and/or high response rates, they are not risk-free. Reports of immune-related adverse events (therapy-dependent toxicities caused by non-specific activation of the immune system) surfaced early in development for ipilimumab and accompany all approved immunotherapies.
The American Association for Cancer Research (AACR) will join the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases, and National Institute of Arthritis and Musculoskeletal and Skin Diseases to convene the NIH-AACR Cancer, Autoimmunity, and Immunology Conference on April 15-16, 2019, in the Masur Auditorium on the National Institutes of Health campus in Bethesda, Maryland.Read More
“Do you want to have fun?” Richard Pazdur, MD, director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, asked the audience as he opened the “PD-1 Pandemonium: FDA Speaks with Industry on the Past, Present, and Future of PD-1 Drugs” regulatory science and policy session at the American Association for Cancer Research (AACR) Annual Meeting 2019 on Monday, April 1.
Pazdur explained that he and AACR staff in the Science Policy and Government Affairs Office thought that it would be informative to convene representatives from all the companies who have an FDA-approved PD-1– or PD-L1–targeted immunotherapeutic for a heart-to-heart conversation about the past, present, and future of this group of revolutionary cancer treatments.Read More