Kristi Rosa

The FDA has approved the BRACAnalysis CDx assay for use as a companion diagnostic to select patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who may derive clinical benefit from treatment with olaparib.

A marketing authorization application has been submitted to the European Medicines Agency for 2 indications of ivosidenib: in combination with azacitidine in the frontline treatment of patients with IDH1-mutated acute myeloid leukemia who are not candidates for intensive chemotherapy and in previously treated patients with locally advanced or metastatic IDH1-mutated cholangiocarcinoma.

The combination of ribociclib and letrozole resulted in a statistically significant improvement in overall survival vs letrozole alone in patients with postmenopausal, hormone receptor–positive, HER2-negative advanced breast cancer, with this benefit continuing to increase over time, supporting the use of this combination as a frontline treatment in this population.

A supplemental new drug application and a Variation Type II application have been submitted to the FDA and the European Medicines Agency, respectively, seeking the approval of darolutamide plus docetaxel in patients with metastatic hormone-sensitive prostate cancer.

The FDA has granted an orphan drug designation to epcoritamab for use as a potential therapeutic option for patients with follicular lymphoma.

Although the addition of copanlisib to ibrutinib resulted in a high overall response rate in patients with relapsed/refractory mantle cell lymphoma, the regimen was found to have additive toxicity, according to findings from a small phase 1 trial.

The phase 3 NuTide:121 trial examining the first-in-class nucleotide analogue NUC-1031 in combination with cisplatin vs gemcitabine plus cisplatin in patients with advanced biliary tract cancer is being discontinued.

The FDA has placed a partial clinical hold on the phase 1 NEON-2 trial examining the combination of davoceticept and pembrolizumab in patients with advanced solid tumors or lymphoma.

Poziotinib elicited encouraging responses when given at a daily dose of 16 mg in the first-line treatment of patients with non–small cell lung cancer with HER2 exon 20 insertion mutations.

Sacituzumab govitecan resulted in a statistically significant improvement in progression-free survival vs physician’s choice of chemotherapy in patients with hormone receptor–positive, HER2-negative metastatic breast cancer who previously received endocrine therapy, CDK4/6 inhibitors, and 2 to 4 lines of chemotherapy, meeting the primary end point of the phase 3 TROPiCS-02 trial.

Pembrolizumab significantly improved distant metastasis–free survival vs placebo when used as an adjuvant treatment in patients with resected stage IIB and IIC melanoma, according to additional data from the phase 3 KEYNOTE-716 trial.

The FDA has granted priority review to a supplemental new drug application seeking the approval of ivosidenib in combination with azacitidine in the treatment of patients with previously untreated IDH1-mutated acute myeloid leukemia.

The FDA has approved nivolumab plus platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer in the neoadjuvant setting.

The FDA has extended the Prescription Drug User Fee Act goal date for the biologics license application and supplemental new drug application seeking the approval of ublituximab plus umbralisib in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

The FDA has granted a to the BCMA-targeting Tri-specific T-cell Activating Construct, HPN217, for use as a potential therapeutic option in patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy.

The FDA has placed a clinical hold on the phase 1b CYAD-101-002 trial, which is examining the safety and clinical activity of the investigational CAR T-cell therapy CYAD-101 given concurrently with FOLFOX and followed by pembrolizumab in patients with unresectable metastatic colorectal cancer.

A supplemental new drug application has been submitted to the FDA seeking the approval of ibrutinib for the treatment of pediatric and adolescent patients aged 1 year and older with chronic graft-vs-host disease following failure of 1 or more lines of systemic therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has confirmed its recommendation to approve the use of enfortumab vedotin in adult patients with locally advanced or metastatic urothelial cancer who have received prior platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.

The FDA has granted priority review to a supplemental biologics license application for the combination of nivolumab and chemotherapy in the neoadjuvant treatment of patients with resectable non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the use of nivolumab in combination with chemotherapy in the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for use as an adjuvant treatment in adult patients with muscle-invasive urothelial carcinoma with a PD-L1 expression of at least 1% on tumor cells, who are at a high risk of recurrence following radical resection.

The novel androgen receptor PROTAC degrader, bavdegalutamide, was found to be clinically active and tolerable with manageable adverse effects in patients with metastatic castration-resistant prostate cancer.

Sotorasib had clinically meaningful activity in heavily pretreated patients with KRAS G12C–mutated advanced pancreatic cancer, according to findings from the phase 1/2 CodeBreaK 100 trial.

The European Medicines Agency has accepted for review 2 new indication applications for zanubrutinib as a therapeutic option for patients with chronic lymphocytic leukemia and for those with marginal zone lymphoma.

The FDA has accepted for review a supplemental new drug application for zanubrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The Data Safety Monitoring Board for the ongoing phase 1/2 OVATION 2 trial has unanimously recommended that patients continue to receive treatment with the novel gene-mediated immunotherapy, GEN-1, at a dose of 100 mg/m2.

The FDA has given the green light to the FoundationOne CDx for use as a companion diagnostic that can be leveraged to identify patients with microsatellite instability high solid tumors who may be candidates to receive and derive benefit from pembrolizumab.

The European Commission has approved tepotinib for use as a single agent in adult patients with advanced non–small cell lung cancer harboring METex14 skipping alterations who require systemic therapy after prior treatment with immunotherapy and/or platinum-based chemotherapy.

Trastuzumab deruxtecan resulted in a statistically significant improvement in progression-free survival and overall survival compared with physician’s choice of chemotherapy in patients with HER2-low unresectable and/or metastatic breast cancer, irrespective of hormone receptor status, meeting the primary and secondary end points of the phase 3 DESTINY-Breast 04 trial.