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.

To sign up for advocacy alerts, log in to ASCO.org with your ASCO member or guest account, and visit the subscription center available under your account profile.

Tune in to ASCO's new ASCO in Action podcast series, providing analysis and commentary on cancer policy and practice issues, available through iTunes or Google Play.

Showing results for FDA

December 10, 2018

On Friday, December 7, President Trump signed into law a two-week Continuing Resolution (CR) to prevent a partial government shutdown.

While Congress was able to pass some of its Fiscal Year (FY) 2019 appropriations bills before the end of the 2018 fiscal year, it has not yet come to agreement on seven remaining appropriations bills, which fund a variety of federal departments and agencies, including the Food and Drug Administration (FDA). The CR will provide flat funding for those agencies until December 21, 2018, when Congress will need to take further action to fund them.

December 6, 2018

ASCO submitted comments to the United States Pharmacopeia Convention (USP) concerning a proposed chapter on pharmaceutical compounding. ASCO is concerned that proposed chapter, General Chapter <797> Pharmaceutical Compounding– Sterile Preparations (USP <797>), as it is currently written, could create unnecessary confusion for providers, interfere with patient access to potentially life-saving drugs, and undermine FDA drug approval requirements.

December 6, 2018

On December 6, 2018, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

November 28, 2018

On November 28, 2018, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

November 28, 2018

On November 28, 2018, the Food and Drug Administration approved gilteritinib (XOSPATA®, Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

November 26, 2018

The Food and Drug Administration (FDA) recently announced new changes to expand and update the Expanded Access (EA) program, which allows very ill patients access to experimental treatments outside of clinical trials. The most recent updates include clarifications on safety data, a new navigation team, a new coordinating committee, and updated web resources.

November 26, 2018

On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI®, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

November 21, 2018

On November 21, 2018, the Food and Drug Administration granted accelerated approval to venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

November 21, 2018

On November 21, 2018, the Food and Drug Administration approved glasdegib (DAURISMO™, Pfizer Labs) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

November 20, 2018

On November 20, 2018, the Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

November 19, 2018

On November 14, the Food and Drug Administration (FDA) announced new action to ban flavored e-cigarettes (e-cigs) at convenience stores. The ban follows the agency’s September announcement of its new Youth Tobacco Prevention Plan to address the alarming rates at which children and young adults are using e-cigs.

November 16, 2018

On November 16, 2018, the Food and Drug Administration approved brentuximab vedotin (ADCETRIS®, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL including sALCL.

November 9, 2018

On November 9, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

November 5, 2018

On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA®, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

October 30, 2018

On October 30, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

Pages