On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.
The target action date for the FDA decision is February 28, 2021.
Read press release.
Posted on 10/29/2020.
Join professionals from across the country for an expert discussion on Lynparza (olaparib, AstraZeneca), and Lynparza + bevacizumab as maintenance monotherapy or combination therapy in advanced ovarian cancer: results from key clinical trials.
Members will be directed to a registration site which will give them the option to choose from all 6 webcasts
Members will be required to input their information to register for an event
Members can add the event to their calendar from the registration site or the registration confirmation email
Members will receive a reminder email 1 day and 30 minutes prior to the webcast
Details and registration.
Zanubrutinib (Brukinsa™, BeiGene) is a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For prescribing information click here, or here for the Dosing and Administration Guide.
To help guide and assist patients during treatment, Beigene has developed a customized and comprehensive support program. The myBeiGene Patient Support program is staffed with nurses who have prior experience working with oncology patients. Practices and their patients get a dedicated Oncology Nurse Advocate assigned to them, and comprehensive patient support, including connecting patients to helpful resources that can address their personal needs.
Posted on 10/07/2020
Tafasitamab-cxix (Monjuvi®, Incyte), in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Join a one-hour webcast to learn more about the usage of Tafasitamab-cxix (Monjuvi®) in treating your patients. For more information, click here.
Posted on 10/06/2020
On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.
Read the FDA Announcement.
Read the Bristol Myers Squibb Announcement.
On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne® Liquid CDx and Guardant360® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
See full prescribing information.
About FoundationOne® Liquid CDx.
About Guardant360® CDx.
On Friday, September 18, 2020 the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Radiation Oncology (RO) Model. The RO Model seeks to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether bundled, prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. The RO Model has a five-year Model performance period that begins on January 1, 2021 and runs through December 31, 2025.
For additional information on the final rule and the model, please visit the radiation oncology website. The following resource documents about RO may also be helpful: Press Release, Fact Sheet, and Final Rule. For questions regarding the RO Model, please reach out to the RO Model Helpdesk by phone: 1.844.711.2664, option 5; or email: RadiationTherapy@cms.hhs.gov.
Join AstraZeneca for a series of expert-led discussions on Lynparza® (olaparib), Lynparza® + bevacizumab, and Enhertu®:
Enhertu® (fam-trastuzumab deruxtecan-nxki)
Wednesday, September 16, 2020
Presented by: Maria Theodoulou, MD, Memorial Sloan-Kettering Cancer Center
Learn More & Register
Lynparza® (olaparib) and Lynparza® + bevacizumab
Tuesday, September 22, 2020
Presented by: Anne O’Dea, MD, University of Kansas Medical Center, and Virginia Kaklamani, MD, DSc, MSCI, University of Texas Health Science Center at San Antonio
Learn More & Register
Wednesday, September 23, 2020
Presented by: Sharyn Lewin, MD, FACS, Holy Name Medical Center
Learn More & Register
Wednesday, September 30, 2020
Presented by: Yuan Yuan, MD, PhD, City of Hope Comprehensive Cancer Center
Learn More & Register
On September 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule, which includes important provisions designed to ensure access to potentially life-saving diagnostics and therapies for hospitalized Medicare beneficiaries. The changes will affect approximately 3,200 acute care hospitals and approximately 360 Long-Term Care Hospitals. CMS estimates that total Medicare spending on acute care inpatient hospital services will increase by about $3.5 billion in FY 2021, or 2.7 percent.
CMS’ rule creates a new Medicare Severity Diagnostic Related Group (MS-DRG) that provides a predictable payment to help adequately compensate hospitals for administering Chimeric Antigen Receptor (CAR) T-cell therapies.
Also in the final rule, CMS approved a record number of 24 new technology add-on payments, which is an additional payment to hospitals for cases involving eligible new and relatively high cost technologies. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations.
Read the fact sheet and final rule from the Federal Register.