FDA’s Office of Hematology and Oncology Products Reorganizes

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.

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Bringing Awareness to Breast Cancer in October

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.

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Use of Pembrolizumab Expanded to 13th Type of Cancer in Five Years

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.

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Second Targeted Therapeutic Approved for Use Based on Tumor Biomarker, Not Tumor Origin

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.

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FDA Approvals Provide Advances for a Range of Cancer Types

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.

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FDA Approvals Provide New Advances Against Bladder, Lung, and Kidney Cancer

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.

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AACR Annual Meeting 2019: Past, Present, and Future of CDK4/6-targeted Therapeutics

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.

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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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