On July 18, 2018, the Food and Drug Administration expanded the indication for ribociclib (Kisqali®, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
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 July 13, 2018, the Food and Drug Administration approved enzalutamide (XTANDI®, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
On July 10, 2018, the Food and Drug Administration granted accelerated approval to ipilimumab (YERVOY®, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
FDA has limited the use of Tecentriq (atezolizumab) and Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. This is due to decreased survival associated with these drugs as single therapy (monotherapy) compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
On June 27, 2018, the Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI™ and MEKTOVI®, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin®, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. The FDA also accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda®, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
On June 8, 2018, the Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
On June 4, 2018, the Food and Drug Administration approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH) as a biosimilar to Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
As nearly 40,000 oncology professionals from around the world gather in Chicago for the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) to learn about the latest in clinical cancer research — from new treatment options and advances in precision medicine to insight for improving access to care — ASCO welcomes the U.S. Food and Drug Administration's (FDA) announcement that it is advancing new policies to make the drug review and approval process more modern, more scientifically rigorous, and more efficient.
Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have been developed and marketed as competitive, lower-cost alternatives to newer biologic treatments. This pathway was established to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. Biosimilars are among the fastest-growing class of drugs in the United States, a class called biological products.
With Congress having recently passed federal "right-to-try" (RTT) legislation, ASCO has developed a suite of educational resources that will help members understand the impact of this law on cancer care and individuals with cancer. Resources include a podcast with guest ASCO Senior Vice President and Chief Medical Officer Dr. Richard Schilsky, FACP, FASCO, FSCT, an issue brief on RTT legislation, and an FAQ for oncologists and their patients.
On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet®, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
On May 18, 2018, the U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
The agenda has been set for the June 22 ASCO/Food and Drug Administration (FDA) “Core Outcome Assessments in Cancer Clinical Trials” workshop.