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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Harnessing the Power of Precision Medicine – Treating Cancers with Tissue-agnostic Therapies

Cancer treatments have been, and continue to be in most cases, based on the organ site where the tumor originates—some treatments are specific for breast cancer, some for lung cancer, and so on. However, rapid advances in genomic sequencing technologies have led to a recent development that deviates from the long-held notion of treating cancers based on the site of origin.

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AACR Applauds FDA’s New Steps to Address Epidemic of Youth E-cigarette Use

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.

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Recent FDA Approvals Signal More Progress Against Cancer

The past month has seen the U.S. Food and Drug Administration (FDA) expand the use of four anticancer therapeutics, providing new treatment options for patients with four types of cancer. On Aug. 16, 2018, the agency approved the immunotherapeutic nivolumab (Opdivo) for treating certain patients with small cell lung cancer and approved the molecularly targeted therapeutic lenvatinib (Lenvima) for treating certain patients with the most common type of liver cancer, hepatocellular carcinoma.

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