ASCO in Action

ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.

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Showing results for Cancer Drugs

November 21, 2022

The American Society of Clinical Oncology (ASCO) recently released an updated position statement on drug repository programs. The update shifts ASCO’s position to allow donation of oral cancer drug treatments in an open distribution system - which are drugs that have left the supply chain and have been dispensed to patients.

November 15, 2022

On November 14, 2022, the Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) for adult patients with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a folate receptor alpha directed antibody and microtubule inhibitor conjugate. Patients are selected for therapy based on an FDA-approved test.

November 10, 2022

On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 

November 10, 2022

On November 10, 2022, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin.

November 9, 2022

On November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.

November 1, 2022

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) released its final rule for the calendar year (CY) 2023 Medicare Physician Fee Schedule and updates to the Quality Payment Program. CMS also released its final rule for the CY 2023 Hospital Outpatient Prospective Payment System the same day. The Association for Clinical Oncology (ASCO) is still assessing the rules, but based on a preliminary analysis, key provisions for the cancer care community are included here.

October 25, 2022

On October 25, 2022, the Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

October 24, 2022

On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC).

September 30, 2022

On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

September 27, 2022

In comments to the Centers for Medicare & Medicaid Services (CMS) on the 2023 Hospital Outpatient Prospective Payment System (OPPS) proposed rule, the Association for Clinical Oncology (ASCO) continues to call for a final rule that supports patient access to high-quality, equitable cancer care and support for oncology providers. Highlights from ASCO’s comments are includeded here.

September 27, 2022

The American Society of Clinical Oncology (ASCO) released a new frequently asked questions (FAQs) document on the safe handling of hazardous drugs, including those used to treat individuals with cancer, as a resource for its members. The FAQ document focuses on the current hazardous drug safe handling standards from the United States Pharmacopeia (USP), the National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA). The document also highlights ASCO’s work for the oncology community on the issue, including its own standards for the safe handling of hazardous drugs, which were released in early 2019.

September 21, 2022

On September 21, 2022, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

September 20, 2022

On September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.

September 20, 2022

On September 20, 2022, the Food and Drug Administration approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors.

August 26, 2022

On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

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