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.
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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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.
What is team-based cancer care and how has it evolved over the past decade? A special series in the American Society of Clinical Oncology’s (ASCO) JCO Oncology Practice highlights transformations in team-based delivery models within the cancer care system and their potential direction.
Cancer research sites demonstrated the utility of new resources designed to increase the diversity of participants in cancer clinical trials, although challenges remain, according to two studies published today in JCO Oncology Practice.
The 118th Congress began January 3, 2023, with a contentious election for Speaker of the House. Due to the multi-day election, members of the House of Representatives were not sworn in until January 7, initiating delays in committee assignments, rules for how the House runs during this session, and the ability of Representatives to do their day-to-day work. All pending legislation expired at the end of 2022 and will need to be reintroduced for the 118th Congress.
On January 11, 2023, the Department of Health and Human Services (HHS) Secretary Xavier Becerra extended the COVID-19 Public Health Emergency (PHE) declaration. The PHE is now set to expire on April 11, 2023.
On December 23, 2022, Congress passed a Fiscal Year (FY) 2023 omnibus funding bill, which funds all federal agencies through September 30, 2023, and includes several health policies, such as mitigating Medicare physician payment cuts, Food and Drug Administration (FDA) reforms, and telehealth expansion. The Association continues to analyze the legislative package and will provide additional details in the coming days.
On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.