Latest News & Updates
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
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…
FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection
On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab (Rybrevant, Janssen Biotech, Inc.). See the prescribing information for the specific indications.
FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer
On December 17, 2025, the Food and Drug Administration approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx).
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer
On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
On December 12, 2025, the Food and Drug Administration approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
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