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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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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