On September 6, 2018, the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research hosted a public workshop, Non-clinical Models for Safety Assessment of Immuno-Oncology Products. Academics, industry, regulators, and biomedical research funders gathered to review the state of the science and discuss opportunities to develop better non-clinical approaches for safety assessment and dose selection for immuno-oncology products in patients, with specific focus on immune checkpoint stimulators and inhibitors (ICS/ICI).Read More
The past two weeks have seen a flurry of U.S. Food and Drug Administration (FDA) approvals of new treatments for acute myeloid leukemia (AML). On Nov. 21, 2018, the FDA approved both glasdegib (Daurismo) and venetoclax (Venclexta) for treating patients with newly diagnosed AML who are age 75 or older, or who have chronic health conditions or diseases that prevent them being treated with the standard intensive chemotherapy. A week later, on Nov. 28, 2018, the agency approved gilteritinib (Xospata) for treating patients whose AML tests positive for a mutation in the FLT3 gene.Read More
On Monday, the U.S. Food and Drug Administration (FDA) announced the highly anticipated approval of the molecularly targeted therapeutic larotrectinib (Vitrakvi) for use based on whether a patient’s tumor tests positive for a specific genetic biomarker and not where in the body the tumor originated.Read More
During the early part of November, we saw the U.S. Food and Drug Administration (FDA) approve a new molecularly targeted therapeutic, lorlatinib (Lorbrena), and expand the use of the immunotherapeutic pembrolizumab (Keytruda). These new approvals, which are for the treatment of certain patients with lung cancer and liver cancer, respectively, highlight that progress in the fields of precision medicine and immunotherapy is continuing unabated.Read More
Thanks to decades of cancer research that have brought us groundbreaking discoveries and treatments, 15.5 million U.S. cancer survivors have more time to spend with their loved ones. That number is only going up, to an estimated 26.1 million by 2040.
For most of these survivors, their journey comes with complications and lasting side effects. Many continue to deal with the physical, mental, and emotional impact of their cancer diagnosis long after their final treatment. Thousands of survivors face financial challenges resulting from or made worse by their cancer diagnosis and treatment.Read More
In the midst of Breast Cancer Awareness Month, the US. Food and Drug Administration (FDA) provided good news for the breast cancer community this week when it approved a new breast cancer therapeutic called talazoparib (Talzenna), which targets ADP-ribose polymerase (PARP) proteins. They also approved a test to identify those patients eligible to receive talazoparib: patients with metastatic or locally advanced, HER2-negative breast cancer who have an inherited, cancer-associated BRCA1 or BRCA2 (BRCA1/2) mutation.Read More
Last week saw a flurry of new anticancer therapeutics approved by the U.S. Food and Drug Administration (FDA) for treating several types of cancer. On Monday, Sept. 24, the agency approved the molecularly targeted therapeutic duvelisib (Copiktra) for treating certain patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and for treating certain patients with follicular lymphoma. On Thursday, Sept. 27, it approved another molecularly targeted therapeutic—dacomitinib (Vizimpro)—for treating certain patients with non–small cell lung cancer (NSCLC). Then, on Friday, Sept. 28, it approved the immunotherapeutic cemiplimab-rwlc (Libtayo) for treating certain patients with cutaneous squamous cell carcinoma.Read More
In 2017, electronic cigarettes (e-cigarettes) were the most commonly used tobacco product among high and middle school students. Many public health experts believe that youth use of e-cigarettes has reached an epidemic proportion.
On September 12, 2018, the U.S. Food and Drug Administration (FDA) announced a series of critical and historic enforcement actions related to the sale and marketing of e-cigarettes to kids. This effort included issuing more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors.Read More
In the midst of the dog days of summer, the U.S. Food and Drug Administration (FDA) has provided good news for the cancer community: It has approved two new anticancer therapeutics for the treatment of four rare types of cancer.Read More
During the early part of summer 2018, the U.S. Food and Drug Administration (FDA) has approved several new anticancer therapeutics and expanded the use of some previously approved anticancer therapeutics to include new types of cancer.Read More