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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Showing results for Cancer Drugs

April 12, 2019

The Food and Drug Administration granted accelerated approval to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
 

April 11, 2019

ASCO submitted testimony to the U.S. House and Senate Appropriations Committees urging them to increase funding for the National Institutes of Health, National Cancer Institute, and Food and Drug Administration.

April 11, 2019

On April 11, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.

April 11, 2019

ASCO submitted its position statement on the impact that Pharmacy Benefit Managers (PBMs) have on cancer care to a U.S. Senate Finance Committee hearing, “Drug Pricing in America: A Prescription for Change, Part III.” PBM representatives testified in-person during the hearing, which was held as part of Congress’ ongoing efforts to address rising prescription drug costs in the United States. In its submission, ASCO reiterated the society’s concerns about the negative effects of certain PBM practices on patients and the cancer care system.  

April 9, 2019

ASCO recently submitted comments to the Department of Health and Human Services (HHS) in response to a proposed rule that would eliminate protection for manufacturer rebates on prescription drugs in the Medicare and Medicaid programs. The society’s comments express a shared concern over rising prescription drug costs and urge HHS to implement policies that make rebate arrangements transparent, while ensuring that efforts to address the problem don’t inadvertently lead to higher out-of-pocket costs for people with cancer.

April 1, 2019

The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) has added a new guide for companies regarding use of the Expanded Access Navigator. This guide is intended to provide small and emerging biopharmaceutical companies with assistance in understanding the procedures for expanded access, developing an expanded access policy for their company, and responding to requests for single-patient expanded access.

April 1, 2019

Three completed cohorts reporting findings in non-small cell lung cancer, breast, and metastatic colorectal cancer from the American Society of Clinical Oncology, Inc.’s (ASCO®) Targeted Agent and Profiling Utilization Registry (TAPUR™) Study were presented in poster sessions during the American Association for Cancer Research (AACR) Annual Meeting 2019. In addition, all seven pharmaceutical companies currently participating in the TAPUR Study have recently renewed their commitment to support it and provide study drugs at no cost for an additional one to three years.

March 22, 2019

The U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma.

March 19, 2019

On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC who received no prior chemotherapy for extensive stage disease and had ECOG performance status 0 or 1.

March 15, 2019

Members of Congress recently introduced oral parity legislation to ensure patients have access to the highest-quality cancer treatment.

March 8, 2019

On March 8, 2019, the Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.

February 28, 2019

On February 28, 2019, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta™, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.

February 25, 2019

On February 22, 2019, the Food and Drug Administration approved trifluridine/ tipiracil tablets (LONSURF®, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

February 25, 2019

On February 25, 2019, the Journal of Oncology Practice published an article on precision medicine as part of the State of Cancer Care in America series, which highlights existing challenges and offers three distinct examples of oncology practices successfully implementing precision medicine programs.

February 15, 2019

President Trump signed into law a funding bill that provides FDA with $3.08 billion in government funding for fiscal year 2019 – a $269 million increase, and the largest boost to FDA in at least five years.

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