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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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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FDA Approves a New PARP Inhibitor for BRCA-mutant Breast Cancer

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.

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Three New Cancer Treatments Approved by the FDA

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.

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