Latest News & Updates
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
June 3, 2025
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)
November 22, 2024
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)
October 25, 2024
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
October 25, 2024
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 gemcitabine intravesical system for non-muscle invasive bladder cancer
September 10, 2025
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary…
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
September 10, 2025
On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules for pediatric patients 2 years of age and older with NF1…
FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations
August 8, 2025
On August 8, 2025, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received…
FDA grants accelerated approval to dordaviprone for diffuse midline glioma
August 7, 2025
On August 6, 2025, the Food and Drug Administration granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals, Inc.), a protease activator, for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
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