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

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.

August 24, 2022

On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. 

August 16, 2022

The Inflation Reduction Act extends Affordable Care Act (ACA) tax credit subsidies, allows Medicare to negotiate prescription drug prices, places inflationary caps on price increases for Medicare Part B and Part D drugs, and limits Medicare beneficiaries’ out-of-pocket spending on Part D prescription drugs.

August 12, 2022

On August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC.

August 11, 2022

On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test. 

August 9, 2022

UPDATE: On August 7, 2022, the Senate passed the Inflation Reduction Act (IRA), a broad climate, tax, and healthcare reconciliation bill, 51 to 50. Healthcare provisions in IRA will extend Affordable Care Act (ACA) premium tax credits, allow Medicare to negotiate prescription drug prices, place inflationary caps on Medicare Part B and Part D drugs, and cap out-of-pocket spending on prescription drugs for Medicare beneficiaries. The House of Representatives will reconvene on August 12 to consider and vote on the legislation--which is expected to pass--after which President Biden will sign the bill into law.

August 5, 2022

On August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. 

August 5, 2022

​On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

August 2, 2022

On August 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long‑Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. In addition to updating Medicare payment rates and policies for inpatient hospital services in FY 2023, the final rule aims to improve beneficiary access, improve the quality of maternity care, and advance health equity.

July 15, 2022

On July 15, 2022, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS). The Association for Clinical Oncology (ASCO) is assessing the full proposal, but ASCO’s initial analysis is included here.

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