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.
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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.
On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) released the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for 2021. Of particular note, CMS is proposing a new Medicare Severity-Diagnosis Related Group (MS-DRG) for chimeric antigen receptor T-cell therapy (CAR T-cell therapy).
ALEXANDRIA, Va. -- Twenty-seven practices elevated their standard of care and achieved Quality Oncology Practice Initiative (QOPI®) Certification in the first quarter of this year. The Association for Clinical Oncology (Association) commends these practices that have demonstrated their commitment to providing the highest-quality oncology care to their patients, communities, and contemporaries.
In the midst of the COVID-19 pandemic, a new ASCO article reports that oncology research programs are experiencing delays and other challenges in advancing clinical trials during this unprecedented time. The article, which published today in JCO Oncology Practice and was previewed during ASCO’s recent presscast on COVID-19 and cancer care, looks at the types of changes and challenges to clinical trials that research sites experienced early in the pandemic. Data from the article comes from a March 2020 survey of oncology research programs, including both academic- and community-based research programs.
The Association for Clinical Oncology (ASCO) recently sent a letter to House and Senate leadership urging their support for policies to increase diversity in clinical trials, including the CLINICAL TREATMENT Act (H.R. 913), in a future COVID-19 response package.
The Association for Clinical Oncology (ASCO) recently submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s draft guidance to encourage the inclusion of older adults in clinical trials of cancer drug treatments.
On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
On May 8, 2020, the Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.
On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTATM, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
The Centers for Medicare & Medicaid Services (CMS) has confirmed ASCO’s Survey on COVID-19 in Oncology Registry (ASCO Registry) is an acceptable clinical trial registry for the attestation of the high-weighted practice Improvement Activity (IA), “COVID-19 Clinical Trials related to the Emergency Response & Preparedness,” under the Merit-based Incentive Payment System (MIPS).
On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPROTM, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.