NIH-AACR Conference Explores Intersection of Cancer, Autoimmunity, and Immunology

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.

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AACR Annual Meeting 2019: PD-1 Pandemonium

“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.

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AACR Annual Meeting 2019: The Biden Cancer Initiative

Like many Americans, Dr. Jill Biden has been personally affected by cancer. Friends, her parents, and her son Beau have all died of the disease, fueling her desire to fight for better treatments.

She and her husband, former Vice President Joe Biden, established the Biden Cancer Initiative to build upon the work begun as part of the Cancer Moonshot Initiative in 2016. Dr. Biden attended the American Association for Cancer Research Annual Meeting 2019 on Sunday to share some of the progress that has been made, and to discuss how collaboration will be important in securing future progress.

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AACR Annual Meeting 2019: NCI Leaders Praise Progress and Collaboration

Two of the nation’s preeminent leaders in cancer research and policy took the stage Sunday morning at the Opening Ceremony of the American Association for Cancer Research Annual Meeting 2019.

Norman “Ned” Sharpless, MD, FAACR, and Douglas R. Lowy, MD, discussed recent progress against cancer from the vantage point of the National Cancer Institute (NCI). Sharpless has served as director of the NCI since October 2017, and will soon leave the agency to become acting commissioner of the U.S. Food and Drug Administration (FDA). Lowy will take over as NCI acting director, a position he held from 2015-2017.

Sharpless and Lowy discussed the rapid pace of progress in cancer care, drug development, clinical trials, and research funding over the past few years, and vowed to continue the momentum in their new roles in Washington, D.C.  

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FDA Approves First Immunotherapeutic for Breast Cancer

Last Friday, March 8, 2019, marked another milestone in immuno-oncology: The U.S. Food and Drug Administration (FDA) announced the first approval of an immunotherapeutic for use in the treatment of breast cancer.

The immunotherapeutic in question is atezolizumab (Tecentriq). It was approved for use in combination with a cytotoxic chemotherapeutic called nab-paclitaxel (Abraxane) for treating adults who have unresectable locally advanced or metastatic triple-negative breast cancer that expresses the protein PD-L1.

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Stakeholder Perspectives on Non-clinical Models for Immuno-Oncology Products

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).

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FDA Approves Three New Treatments for AML

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.

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FDA Approves First Targeted Therapeutic Based on Tumor Biomarker, Not Tumor Origin

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.

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FDA Approvals Provide Advances in Precision Medicine and Immunotherapy

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.

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