Latest News & Updates
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The FDA previously approved darolutamide in combination with docetaxel for mCSPC.
A Phase 3 Study of elacestrant versus standard endocrine therapy in node-positive ER+, HER2- early breast cancer with high risk of recurrence (ELEGANT)
Despite advances in the adjuvant treatment of early-stage estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, there continues to be a risk of recurrence. The ELEGANT study is a Global, Multicenter, Randomized, Open-label Phase 3 Study with the primary goal to evaluate the efficacy and safety of elacestrant versus standard endocrine…
Applications Are Open for the ASCO Quality Training Program (QTP)
ASCO’s Quality Training Program (QTP) Winter 2025 Session will be on the following dates, hosted by Memorial Healthcare System in Pembroke Pines, Florida: Learning Session 0 (Orientation): Thursday, December 5, 2024 (Virtual) Learning Session 1: Thursday, January 9 – Friday, January 10, 2025 (in-person) Learning Session 2: Thursday, March 6 – Friday, March 7, 2025…
Merit-based Incentive Payment System (MIPS) Automatic Extreme and Uncontrollable Circumstances (EUC) Policy Applied to MIPS Eligible Clinicians Following Hurricanes Helene and Francine
The U.S. Department of Health and Human Services (HHS) Secretary Becerra recently released a letter to healthcare leaders and stakeholders on the impacts of Hurricane Helene, which can be found on the HHS website. In response to Hurricanes Helene and Francine, the Centers for Medicare & Medicaid Services (CMS) has determined that the MIPS automatic…
FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma
On November 25, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021.
FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.
FDA approves epcoritamab-bysp for follicular lymphoma indications
On November 18, 2025, the Food and Drug Administration approved epcoritamab-bysp (Epkinly, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for…
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The Corporate Partnership Program allows FLASCO to expand our offerings to our partners. 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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