ONCOLOGY NEWSFEED

The FDA granted accelerated approval to sunvozertinib for select adult patients with locally advanced or metastatic non-small cell lung cancer.

For more information, read the FDA announcement and visit the Dizal (Jiangsu) Pharmaceutical website .

The FDA granted accelerated approval to linvoseltamab-gcpt for select adults with relapsed or refractory multiple myeloma.

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

The FDA granted accelerated approval to datopotamab deruxtecan-dlnk for select adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

For more information, read the FDA announcement and visit the Daiichi Sankyo website .

The FDA approved tafasitamab-cxix with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.

For more information, read the FDA announcement and the Incyte Corporation press release .

The FDA approved mitomycin intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

For more information, read the FDA announcement and visit the UroGen Pharma website .

The FDA approved a new tablet formulation of zanubrutinib for all 5 approved indications.

For more information, visit the BeOne Medicines website .

The FDA approved taletrectinib a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.

For more information, read the FDA announcement and the Nuvation Bio press release .

The FDA approved darolutamide for metastatic castration-sensitive prostate cancer.

For more information, read the FDA announcement and the Bayer Healthcare Pharmaceuticals Inc press release .

The FDA recently approved retifanlimab-dlwr with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

For more information, read the FDA announcement and the Incyte Corporation press release .

The FDA granted accelerated approval to telisotuzumab vedotin-tllv a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy.

For more information, read the FDA announcement and the AbbVie Inc. press release.

The FDA recently approved belzutifan for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

For more information, read the FDA announcement and the Merck & Co., Inc. press release .

The FDA granted accelerated approval to the combination of avutometinib and defactinib for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

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

FDA approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma and as a single agent for adults with metastatic non-keratinizing NPC.

For more information, read the FDA announcement .

The FDA approved nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

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

On April 10, the US Food and Drug Administration (FDA) approved larotrectinib, a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity.

For more information, read the Bayer press release .

On March 28, the US Food and Drug Administration (FDA) expanded the indication for lutetium Lu 177 vipivotide tetraxetan to include adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy.

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

On April 8, the US Food and Drug Administration (FDA) approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer.

For more information, read the FDA announcement .

On March 28, the US Food and Drug Administration (FDA) approved durvalumab with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle-invasive bladder cancer.

For more information, read the FDA announcement .

On March 26, the US Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients aged 12 years or older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.

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

On March 19, the US Food and Drug Administration (FDA) granted traditional approval to pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.

For more information read the FDA announcement .

On March 11, the European Commission granted marketing authorization for imetelstat as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low, or intermediate-risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic abnormality who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

For more information, read the Geron press release .

On March 4, the US Food and Drug Administration (FDA) approved tislelizumab-jsgr in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.

For more information, read the Beigene press release .

On January 27, the US Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

For more information, read the FDA announcement and the Daiichi Sankyo press release.

On February 14, the US Food and Drug Administration (FDA) approved vimseltinib, a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumors for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

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