Kristi Rosa

The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.

The FDA has approved the FoundationOne CDx for use as a companion diagnostic to determine which patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 substitutions may derive benefit from EGFR TKIs that have been greenlit by the agency for this indication.

At a median follow-up of 3.5 years, adjuvant olaparib significantly improved overall survival vs placebo in patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who received prior chemotherapy before or after surgery.

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

Allarity Therapeutics, Inc. has filed a formal request with the FDA to hold a Type C meeting where they can discuss possible clinical paths to support the approval of dovitinib in renal cell carcinoma, as well as its DRP-Dovitinib companion diagnostic.

The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.

The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.

Amcenestrant did not improve progression-free survival per independent central review vs physician’s choice of endocrine treatment in select patients with locally advanced or metastatic, estrogen receptor–positive, HER2-negative breast cancer, missing the primary end point of the phase 2 AMEERA-3 trial.

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.

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.