Industry News
Read the latest news that impacts the oncology community.
U.S. FDA grants accelerated approval to Boehringer’s HERNEXEOS® as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC
Ridgefield, Conn. and Ingelheim, Germany [August 8, 2025] -- Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.1
Read MoreJazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma
DUBLIN, Aug. 6, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of 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.1
Read MoreAdaptive Biotechnologies and Flatiron Health Announce Integration of clonoSEQ® MRD Testing into OncoEMR®
SEATTLE, July 01, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, and Flatiron Health, a leading healthtech company dedicated to expanding the possibilities of point-of-care solutions in oncology, today announced the integration of Adaptive’s clonoSEQ® test for measurable residual disease (MRD) assessment in lymphoid malignancies into OncoEMR®, Flatiron’s cloud-based Electronic Medical Record (EMR) platform.
Read MoreU.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma.
Read MoreIncyte Announces FDA Approval of Monjuvi® (tafasitamab-cxix) in Combination with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma
WILMINGTON, Del.--(BUSINESS WIRE)--Jun. 18, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
Read MoreIncyte Announces FDA Approval of Zynyz® (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States
WILMINGTON, Del.--(BUSINESS WIRE)--May 15, 2025-- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the FDA granted approval for Zynyz as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
Read MoreU.S. Food and Drug Administration Approves Nuvation Bio`s IBTROZI™ (taletrectinib)
Nuvation BIO is happy to share that the US Food and Drug Administration (FDA) has approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This exciting approval provides a new targeted tyrosine kinase inhibitor (TKI) for patients with this rare and aggressive disease.
Read MorePress Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector
Paris, June 3, 2025. New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa’s efficacy and safety profile.
Read MoreFDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression
On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.
Read MoreNovocure`s Optune Lua® Receives CE Mark Approval for the Treatment of Metastatic Non-Small Cell Lung Cancer
BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced today that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.
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