As 2019 draws to a close, the American Association for Cancer Research (AACR) is grateful for our growing ranks of cancer patients and survivors who join us in advocating for strong federal funding for medical research. This year, Tomma Hargraves and Nicole Robinson joined us on Capitol Hill for the Rally for Medical Research, an annual gathering in which more than 300 national organizations ask lawmakers to make continued funding for the National Institutes of Health a priority.Read More
Earlier this month, the U.S. Food and Drug Administration (FDA) announced that the Office of Hematology and Oncology Products (OHOP), which is responsible for reviewing cancer therapies, has been reorganized into the Office of Oncologic Diseases (OOD) as part of a broader effort within the Center for Drug Evaluation and Research to modernize its New Drugs Regulatory Program.Read More
On Wednesday, the U.S. Food and Drug Administration (FDA) expanded the use of the molecularly targeted therapeutic niraparib (Zejula) to include an additional group of patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer: those whose cancer has progressed despite treatment with at least three different cytotoxic chemotherapy regimens and tests positive for a new biomarker called homologous recombination deficiency (HRD).Read More
Breast cancer can be a scary diagnosis. Even though mortality rates have declined in recent years in the United States, it is estimated that over 40,000 women and roughly 500 men will die from breast cancer in 2019. Despite progress in developing new treatment modalities for patients with this disease, there is still substantial work to be done in the field.Read More
The use of immunotherapy in the treatment of cancer has dramatically increased in the five years since the U.S. Food and Drug Administration (FDA) first approved the groundbreaking immunotherapeutic pembrolizumab (Keytruda). Since that September 2014 approval, for melanoma, pembrolizumab has been approved for use in the treatment of another 12 types of cancer, most recently endometrial cancer, and the treatment of any type of solid tumor that tests positive for either of two specific biomarkers, microsatellite instability–high or mismatch repair–deficient.Read More
In the effort to include more diverse patient populations in clinical trials, good intentions can easily go awry.
Panelists in the “Addressing Advocacy at the Bench: Implementing Change” session held Sunday …
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 and physician-scientists in the policymaking process has never been greater.Read More
Last week, the U.S. Food and Drug Administration (FDA) approved the second of a new wave of molecularly targeted therapeutics that can be used to treat patients with any type of cancer provided their tumor tests positive for a specific biomarker.
The therapeutic in question, entrectinib (Rozlytrek), was approved for treating adults and adolescents age 12 and older whose cancers have an NTRK gene fusion and who have no other effective treatment options.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