Latest News & Updates

New Guidance on Medicare Inflation Rebates Adjusts for Drug Shortages
CMS published revised guidance on the Medicare Prescription Drug Inflation Rebate Program. That program was established under the Inflation Reduction Act (IRA), which requires drug companies to pay a rebate to Medicare if they raise their prices for certain drugs faster than the rate of inflation. Specifically, IRA established inflation rebates for single-source drugs and…

Is it time to retain your fingerprints?
Every physician who applies for licensure in Florida on or after January 1, 2013 must submit to the Department of Health a set of fingerprints as part of the background screening process. Once the fingerprints are submitted, the information is stored in Florida’s Care Provider Background Screening Clearinghouse. The stored fingerprints must be retained by…

Drug Shortages
What’s Happening: The ongoing and, in some cases, worsening shortages of critical oncology drugs are impacting patients and their oncology care team. ASCO is engaging with congressional leaders on both sides of the aisle and in the House and Senate on proposals to mitigate drug shortages. The lack of predictability in the generic cancer drug supply chain can have severely negative impacts on patients with cancer, including disruptions or delays in treatment, potentially leading to irreversible disease progression. Both Congress and the Administration need to intervene to secure the pharmaceutical pipeline and address drug shortages.

CMS Investigative Study to Examine Benefit of Multi-Cancer Early Detection Tests for Medicare Beneficiaries
A Pathway to Coverage Once Tests Show Clinical Benefit a Critical Next Step WASHINGTON, DC – November 20, 2023 – Grail, LLC announced this morning that the Centers for Medicare and Medicaid Services (CMS) and Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) study for the company’s Galleri multi-cancer early detection (MCED) test…

FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer
On December 15, 2023, the Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy. Full prescribing information for Padcev and Keytruda…

FDA approves belzutifan for advanced renal cell carcinoma
On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Full prescribing information for Welireg will be posted here. Efficacy…

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma
On December 13, 2023, the Food and Drug Administration approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. This represents the first FDA approval of a therapy intended…

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma
On December 1, 2023, the Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. Prescribing information for Jaypirca will be posted here….
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The Corporate Partnership Program allows FLASCO to expand our offerings to our partneres. Every FLASCO meeting also provides the industry representative with opportunities to educate our partners. When you send representatives to a FLASCO meeting, you are allowing them to share their knowledge, as well as receive the same knowledge as our members by participating within the educational sessions. This helps ensure that the hematology and oncology community at large are learning, sharing best practices, and finding solutions to problems together.
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