Chris Ryan

Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.

The FDA has granted priority review to the supplemental new drug application seeking the approval of osimertinib in combination with chemotherapy for the treatment of patients with EGFR-mutated locally advanced or metastatic non–small cell lung cancer.

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

The FDA has approved FoundationOne® CDx and FoundationOne Liquid CDx for use as companion diagnostics to identify patients with metastatic non–small cell lung cancer harboring BRAF V600E mutations who may benefit from treatment with the combination of encorafenib plus binimetinib.

First-line treatment with the universal cancer vaccine UV1 in combination with pembrolizumab sustained overall survival in patients with advanced unresectable or metastatic malignant melanoma, according to updated data from cohort 1 of the phase 1 UV1-103 trial.

Treatment with intratumoral large surface area microparticle paclitaxel led to disease control and was well tolerated in patients with locally advanced pancreatic cancer.

The addition of TPST-1120 to the combination of atezolizumab and bevacizumab led to improved responses vs atezolizumab plus bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.

Treatment with the combination of the investigational oral innate immune activator BXCL701 and pembrolizumab led to a median overall survival of 13.6 months in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer.

The duration of treatment with the combination of venetoclax and ibrutinib could be guided by both toxicities and minimal residual disease kinetics in previously untreated patients with intermediate-risk chronic lymphocytic leukemia, according to interim results from the phase 2 ERADIC trial.

The FDA has placed a partial clinical hold on investigational new drug application for lacutamab, leading to a pause in new patient enrollment for the phase 2 TELLOMAK trial and a phase 1b trial, which are evaluating the agent in patients with advanced cutaneous T-cell lymphoma and peripheral T-cell lymphoma, respectively.

In a 14-to-6 vote, the FDA’s Oncologic Drugs Advisory Committee voted sufficient evidence has been provided to demonstrate the event-free survival benefit of eflornithine to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma.

In a 10-to-2 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the data for progression-free survival per blinded independent central review from the phase 3 CodeBreaK 200 trial evaluating sotorasib vs docetaxel for the treatment of patients with pretreated, locally advanced or metastatic KRAS G12C–mutated non–small cell lung cancer cannot be reliably interpreted.

First-line treatment with the combination of motixafortide, cemiplimab-rwlc, gemcitabine, and nab-paclitaxel elicited responses in patients with metastatic pancreatic adenocarcinoma, according to initial data from the pilot portion of a phase 2 trial.

The FDA has approved the CRCdx® RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer, according to an announcement from EntroGen.

Ablative preoperative stereotactic partial breast irradiation plus endocrine therapy was safe at a single fraction of 34 Gy and generated pathological complete responses and near complete responses in patients with early-stage, estrogen receptor-positive breast cancer.

The FDA has granted a fast track designation to BI 764532 for the treatment of patients with extensive-stage small cell lung cancer that has progressed following at least 2 prior lines of treatment, and for patients with advanced or metastatic extrapulmonary neuroendocrine carcinoma that has progressed following at least 1 prior line of treatment.

The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.

The FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test designed to detect genetic variants associated with an elevated risk of developing certain types of cancer.

Treatment with the first-in-class menin inhibitor revumenib generated complete remissions or complete remissions with partial hematological recovery in adult and pediatric patients with relapsed/refractory acute myeloid leukemia or acute lymphoblastic leukemia harboring KMT2A rearrangements.

The FDA has approved the Empaveli Injector designed to enhance the self administration of pegcetacoplan, which is approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.

The FDA has granted priority review to the biologics license application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.

Treatment with the interleukin-12 gene-mediated immunotherapy IMNN-001 in combination with neoadjuvant platinum chemotherapy led to an improvement in progression-free survival compared with neoadjuvant chemotherapy alone in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

First-line treatment with the combination of amivantamab and lazertinib resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.

Treatment with the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone generated high rates of minimal residual disease negativity in patients with newly diagnosed, high-risk multiple myeloma, irrespective of transplant status.

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy.

The FDA has granted fast track designation to ABM-1310 for the treatment of patients with glioblastoma harboring BRAF V600E mutations.

The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and PARP inhibitor therapies.

First-line treatment with lutetium Lu 177 dotatate plus long-acting octreotide led to a statistically significant and clinically meaningful improvement in progression-free survival compared with high-dose long-acting octreotide alone in newly diagnosed patients with somatostatin receptor–positive, grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors.

The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.