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).
ASCO 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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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.
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.
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.
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.
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.
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.
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.
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.
On February 22, 2017, the U.S. Food and Drug Administration approved lenalidomide (Revlimid®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
On February 2, 2017, the U.S. Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
We commend the Food and Drug Administration (FDA) for establishing the Oncology Center of Excellence (OCE) with Dr. Richard Pazdur as its director. The FDA has provided not only regulatory guidance but also intellectual leadership in the development of oncology products and this new OCE will build on that past, creating a larger community of scientists and clinician experts within the agency. ASCO looks forward to working with the OCE and the new administration to help improve the lives of people living with cancer.
On January 17, the Food and Drug Administration (FDA) outlined the criteria companies must meet to get a biologic deemed interchangeable with its branded counterpart in draft guidance. Interchangeable biosimilars are expected to offer greater savings to the health system than biosimilars that lack this designation.