ONCOLOGY NEWSFEED

On December 27, the

US Food and Drug Administration

approved tislelizumab-jsgr in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.

For more information, read the BeiGene press release .

On December 27, the US Food and Drug Administration approved nivolumab and hyaluronidase-nvhy for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib.

For more information, read the FDA announcement and the Bristol Myers Squibb press release .

On December 17, the US Food and Drug Administration approved blinatumomab for 72- and 96-hour infusion durations to offer more flexibility for physicians and their patients.

For more information visit the BLINCYTO website .

On December 20, the US Food and Drug Administration granted accelerated approval to encorafenib with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

For more information read the FDA announcement and the Array BioPharma press release .

On December 18, the US Food and Drug Administration approved remestemcel-L-rknd, an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.

For more information read the FDA announcement and visit the Mesoblast website .

On December 18, the US Food and Drug Administration approved ensartinib for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.

For more information read the FDA announcement and visit the Xcovery Holdings website .

On December 13, the US Food and Drug Administration approved cosibelimab-ipdl, a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

For more information read the FDA announcement and the Checkpoint Therapeutics press release .

On December 4, the US Food and Drug Administration (FDA) approved durvalumab for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

For more information, read the FDA announcement or the AstraZeneca press release .

On December 4, US the Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab-zbco for adults with the following:

• advanced, unresectable, or metastatic non-small cell lung cancer harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
• advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.

For more information, read the FDA announcement or the Merus N.V. press release .

On November 20, the US Food and Drug Administration (FDA) granted accelerated approval to zanidatamab-hrii, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive IHC 3+ biliary tract cancer, as detected by an FDA-approved test.

For more information read the FDA announcement and the Jazz Pharmaceuticals press release .

On November 19, the US Food and Drug Administration (FDA) approved updated drug labeling for fludarabine phosphate under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.

For more information read the FDA announcement and visit the Sandoz website .

On November 15, the US Food and Drug Administration (FDA) approved revumenib, a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation in adult and pediatric patients 1 year and older.

For more information, read the FDA announcement and the Syndax Pharmaceuticals press release .

On November 8, the US Food and Drug Administration (FDA) approved obecabtagene autoleucel, a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

For more information read the FDA announcement and visit the Autolus website .

Anemia is a hallmark of MDS, conferring heightened mortality risk and diminished quality of life. Please feel free to view & share this important resource.

View Resource

On October 29, the US Food and Drug Administration (FDA) granted accelerated approval to asciminib for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

For more information read the FDA announcement and the Novartis announcement .

On October 18, the American Medical Association introduced new Category I Current Procedural Terminology codes for scalp cooling services, effective January 2026. This change will enhance insurance reimbursement, making scalp cooling more accessible to cancer patients undergoing chemotherapy.

For more information read the PR Newswire announcement .

On October 15, the US Food and Drug Administration (FDA) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.

For more information read the Novocure announcement .

On October 3, the US Food and Drug Administration (FDA) approved nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

For more information read the FDA announcement .

On September 27, the US Food and Drug Administration (FDA) granted traditional approval to selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

For more information read the FDA announcement .

On September 25, the US Food and Drug Administration (FDA) approved osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

For more information read the FDA announcement .

On September 20, the US Food and Drug Administration (FDA) approved isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

For more information read the FDA announcement and the Sanofi-Aventis US LLC announcement .

On September 19, the US Food and Drug Administration (FDA) approved amivantamab-vmjw with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

For more information read the FDA announcement and the Johnson & Johnson announcement .

On September 17, the US Food and Drug Administration (FDA) approved pembrolizumab with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.

For more information read the FDA announcement and the Merck announcement .

On September 17, the US Food and Drug Administration (FDA) approved ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack for the same indication.

For more information read the FDA announcement and the Novartis Pharmaceuticals Corporation announcement .