ASCO in ActionASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.

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June 21, 2017

ASCO joined more than 35 other organizations, including professional societies, patient advocacy groups, and research institutions, to encourage the U.S. Food and Drug Administration (FDA) to develop a guidance on plain language summaries for clinical trials results.

June 9, 2017

On June 6, 2017, the U.S. Food and Drug Administration approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

May 23, 2017

On May 19, ASCO submitted comments to Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, on the FDA’s proposed guidance for industry on demonstrating interchangeability of biosimilars with a reference product. In ASCO’s comments to the FDA, the society took the opportunity to reiterate its strongly held position that physicians and patients should have the ability to select evidence-based treatment options – including the specific biologic product – most appropriate for the patients’ circumstance.

May 10, 2017

ASCO submitted comments to congressional committees regarding the Food and Drug Administration (FDA) Reauthorization Act, which Congress expects to take up before the current authorization expires on September 30, 2017.

May 10, 2017

ASCO submitted comments to congressional committees regarding the Food and Drug Administration (FDA) Reauthorization Act, which Congress expects to take up before the current authorization expires on September 30, 2017.

May 10, 2017

On May 10, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA® , Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).

April 7, 2017

The U.S. Food and Drug Administration has granted marketing authorization to ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV). 

March 31, 2017

On March 31, 2017, the U.S. Food and Drug Administration granted regular approval to palbociclib (IBRANCE®, Pfizer Inc.) for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.

March 30, 2017

On March 30, 2017, the U.S. Food and Drug Administration granted regular approval to osimertinib (TAGRISSO® , AstraZeneca Pharmaceuticals, LP) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. 

March 27, 2017

On March 27, 2017, the U.S. Food and Drug Administration approved niraparib (ZEJULA™, Tesaro, Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

March 23, 2017

On March 23, 2017, the U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.

March 22, 2017

The U.S. cancer care delivery system is undergoing profound changes to better meet the needs of people with cancer, but persistent hurdles threaten to slow progress, according to ASCO's fourth annual State of Cancer Care in America report released March 22, 2017.

March 14, 2017

On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.

March 13, 2017

On March 13, 2017, the U.S. Food and Drug Administration approved ribociclib (KISQALI®, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

March 13, 2017

On March 8, ASCO held a workshop on streamlining adverse events (AE) reporting for cancer clinical trials. Led by ASCO Past President Julie M. Vose, MD, MBA, FASCO, and ASCO President Daniel F. Hayes, MD, FACP, FASCO, the workshop focused on developing a roadmap for making AE reporting as meaningful and informative as possible and overcoming current issues with the reporting process.

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