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
Exelixis Access Services® (EASE) provides a variety of support to help your patients get started on cabozantinib (Cabometyx®)as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey.
Exelixis has issued prescribing information for cabozantinib (Cabometyx®), which is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib as well as a series of resources that you can utilize in your practice.
Access Prescribing Information and Resources.
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.
Lilly announces their Thyroid Cancer Testing Program designed to provide access to molecular testing for appropriate advanced or metastatic medullary thyroid cancer (“MTC”) patients 12 years of age and older who require systemic therapy; and advanced or metastatic non-medullary thyroid cancer (“non-MTC”) patients 12 years of age and older who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Appropriate patients are eligible for one molecular test at no cost for the purpose of determining whether the patient has any actionable genetic alterations that may inform therapeutic decisions, without regard to purchase of any prescribed drug or any other product.*
No patient, healthcare program, payer, or beneficiary shall be billed for any test ordered pursuant to the Thyroid Cancer Testing Program.
To request a test for your patient <and understand further requirements>, you may download the Thyroid Cancer Testing Program Test Request Form.
The Thyroid Cancer Testing Program is NOT available to New York State patients and facilities as the aforementioned NGS tests have not been approved by the New York State Department of Health.