On February 9, 2023, the Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
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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“ASCO applauds President Biden’s focus on ‘ending cancer as we know it’ during the State of the Union address. We continue to urge the president to keep cancer care and research as top national priorities and are pleased with his plans to advance efforts to strengthen the Cancer Moonshot, improve cancer clinical trials, and foster breakthroughs through the Advanced Research Projects Agency for Health (ARPA-H).”
In anticipation of President Biden’s State of the Union Address, the Association for Clinical Oncology (ASCO) is urging the president to keep cancer care and research as top national priorities.
On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Dedicated to making a world of difference in cancer care, the American Society of Clinical Oncology and its affiliated organization, the American Association of Clinical Oncology (ASCO), laud the goals, progress, and continued potential of the Cancer Moonshot initiative. Having the full support of the President and the resources of the federal government is essential to our shared goal of accelerating the pace of progress against a disease that will be diagnosed in more than 1.9 million people in the U.S. this year.
The Association for Clinical Oncology (ASCO) submitted comments in response to the Centers for Medicare & Medicaid Services’ (CMS) Patient Protection and Affordable Care Act 2024 Notice of Benefit and Payment Parameters proposed rule. ASCO’s comments support proposals aimed at reducing or eliminating gaps in health care coverage, and the Association continues to advocate for beneficiary protections by opposing the use of copay accumulator programs.
On January 30, 2023, President Biden announced the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023. This announcement comes after the Department of Health and Human Services (HHS) Secretary Xavier Becerra extended the PHE earlier in January.
With 2023 state legislative sessions underway, the Association for Clinical Oncology (ASCO) and State Affiliates are continuing collaborations to advanced shared advocacy priorities at the state level. ASCO’s 2023 state advocacy priorities include prior authorization and step therapy reform, fertility preservation coverage, Medicaid expansion, drug repository programs, and copay accumulators.
On January 27, 2023, the Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
On January 27, 2023, the Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
the Association for Clinical Oncology (ASCO), along with more than 100 other provider organizations, sent a letter to Members of Congress urging them to preserve access to high-quality care for beneficiaries by reforming the Medicare payment system. The letter urges Congress to hold hearings and work with stakeholders, such as ASCO, this year to identify long-term payment solutions.
On January 26, 2023, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).
On January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
On January 19, 2023, the Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
After direct advocacy from the Association for Clinical Oncology (ASCO) and its members, in December 2020 Congress enacted the CLINICAL TREATMENT Act, which requires all states and territories to cover and reimburse routine costs of care for treating a Medicaid enrollee who is participating in a qualifying clinical trial.