On May 29, 2020, the Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ® and AVASTIN®, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic 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.
To sign up for advocacy alerts, log in to ASCO.org with your member or guest account, and visit the subscription center available under your account profile.
On May 29, ASCO's CancerLinQ® announced it had launched a new platform for CancerLinQ Discovery®, its de-identified real-world cancer data product for researchers across the cancer community.
On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
In an open letter, the Regulatory Relief Coalition (RRC) called on all health plans in the United States to suspend prior authorization requirements for both COVID-19 and non-COVID-19-related services during the novel coronavirus pandemic.
On May 22, 2020, the Food and Drug Administration approved brigatinib (ALUNBRIG®, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.
ASCO released the ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic, which provides detailed guidance to oncology practices on the immediate and short-term steps that could be taken to help protect the safety of patients and healthcare staff before resuming more routine care operations during the COVID-19 public health crisis.
On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no EGFR or ALK genomic tumor aberrations.
A new infographic in the May 2020 print and online issues of JCO Oncology Practice (JCO OP) outlines paths to implementing the American Society of Clinical Oncology’s (ASCO) Patient-Centered Oncology Payment (PCOP) model—an alternative payment model designed to support transformation in cancer care delivery and reimbursement while ensuring that patients with cancer have access to high-quality care. Along with the infographic, the latest issue of JCO OP features an in-depth overview of recent changes to PCOP and two invited commentaries on the model.
On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK™, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
On May 14, 2020, the Food and Drug Administration expanded the indication of pomalidomide (POMALYST®, Celgene Corporation) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative.
A safety update related to the drug BLINCYTO® (blinatumomab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program was announced.
On May 7, 2020, the Centers for Medicare & Medicaid Services (CMS) released the Patient Protection and Affordable Care Act 2021 Notice of Benefit and Payment Parameters final rule, which updates the regulatory and financial standards for Affordable Care Act (ACA) Exchanges. The rule finalized a policy that gives insurers the discretion to not count any form of direct support from drug manufacturers to enrollees for specific prescription drugs toward the annual limit on patient cost sharing amounts.