ONCOLOGY NEWSFEED

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 .

On September 12, the US Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.

For more information read the FDA announcement and the Genentech, Inc. announcement .

On August 26, the

US Food and Drug Administration

(FDA) granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase targeting chimeric degradation activation compound, for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have been previously treated with at least two prior lines of therapy, including BTK inhibitor and B-cell lymphoma 2 inhibitor.

For more information read the BeiGene announcement .

On August 19, the US Food and Drug Administration (FDA) approved lazertinib in combination with amivantamab-vmjw for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

For more information read the FDA announcement .

On August 15, the US Food and Drug Administration (FDA) approved durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery 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 and the AstraZeneca announcement .

On August 14, the US Food and Drug Administration (FDA) approved axatilimab-csfr, a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

For more information read the FDA announcement and the Incyte Corporation announcement .

On July 30, the US Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

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

Posted 7/31/2024

On July 26, Geron Corporation announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of to recommend RYTELO™ (imetelstat) as a Category 1 and 2A treatment of symptomatic anemia in patients with lower-risk Myelodysplastic Syndromes. Treatments are classified as Category 1 and 2A when there is uniform NCCN consensus ≥85% that the intervention is appropriate.

For more information read the Geron announcement .

Posted 7/26/2024

On June 13, the US Food and Drug Administration (FDA) granted accelerated approval to repotrectinib for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

For more information read the FDA announcement and the Bristol Meyers Squibb announcement .

Posted 7/2/2024

On June 26, the US Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

For more information read the FDA announcement and the Genmab Inc. announcement .

Posted 6/27/2024

On June 21, the US Food and Drug Administration (FDA) granted accelerated approval to adagrasib in combination with cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.

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

Posted 6/24/2024