Bipartisan leaders of the House Energy and Commerce Committee introduced a comprehensive legislative package to reauthorize the Food and Drug Administration (FDA) user fee agreements. The package included provisions to strengthen the accelerated approval process and increase diversity of clinical trials.
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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The Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs final rule. The rule finalizes the administration’s efforts to improve consumer protections, reduce disparities, and improve equity in the MA and Medicare Part D programs in 2023 and beyond.
On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.
On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
On March 21, 2022, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
On March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.
Congress is considering several cancer policy priorities this week, including the PREVENT Pandemics Act, Cures 2.0, and legislation to authorize ARPA-H.
The U.S. Food and Drug Administration and the American Society of Clinical Oncology are holding a free virtual workshop, May 3 - 5, on dose optimization for anticancer drug treatment. This timely workshop will bring together thought leaders from academia, industry, regulatory agencies, and patient groups to discuss challenges and opportunities to improve dose selection for patients.
On March 11, 2022, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals, LP) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib.
The College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO) hosted a virtual Immune Checkpoint Inhibition (ICI) Predictive Factor Summit to bring together stakeholders from the U.S. Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), National Institutes of Health (NIH), health insurance organizations, pharmaceutical companies, in vitro diagnostics manufacturers, and patient advocate organizations.
On March 4, 2022, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.
The Association for Clinical Oncology (ASCO) joined with more than 100 organizations to urge Congress to support President Biden’s reinvigorated Cancer Moonshot and to allocate funding to support the initiative.
On February 28, 2022, the Food and Drug Administration approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
On January 25, 2022, the Food and Drug Administration approved tebentafusp-tebn (Kimmtrak, Immunocore Limited), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
The Centers for Medicare & Medicaid Services (CMS) released the 2023 Medicare Advantage and Part D proposed rule. The proposal aims to advance the administration’s efforts to improve consumer protections, reduce disparities, and improve health equity in Medicare Advantage (MA) and Part D.