Kristi Rosa

The FDA has granted a breakthrough therapy designation to IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm.

The immunotherapy combination of adjuvant nivolumab and ipilimumab failed to lead to a statistically significant improvement in recurrence-free survival in the intent-to-treat population of patients with resected stage IIIB/C/D or stage IV melanoma.

The novel somatostatin analog for the Targeted Alpha-emitter Therapy 212Pb-DOTAMTATE has demonstrated early efficacy and a tolerable safety profile in a small cohort of patients with metastatic somatostatin receptor–expressing neuroendocrine tumors irrespective of location of the primary tumor.

Retreatment with Lutathera-based peptide receptor radionuclide therapy has been shown to have an encouraging survival benefit with an acceptable safety in patients with neuroendocrine tumors.

The FDA has issued a complete response letter to Mesoblast Limited regarding a biologics license application for remestemcel-L, recommending that at least 1 additional randomized, controlled study be conducted in adult and/or pediatric patients to provide further evidence of the efficacy of the agent in steroid-refractory acute graft-versus-host disease.

An agreement has been reached to submit a new drug application for the potential accelerated approval of the JAK2/FLT3 inhibitor pacritinib for use in patients with myelofibrosis and severe thrombocytopenia.

Relugolix was not found to achieve statistical superiority with regard to castration resistance–free survival versus leuprolide acetate in patients with metastatic prostate cancer through 48 weeks.

Final data from the pivotal phase 3 ARAMIS trial with darolutamide and androgen deprivation therapy showed that the combination continued to demonstrate a statistically significant improvement in overall survival versus ADT alone in patients with nonmetastatic, castration-resistant prostate cancer.

Frontline sintilimab injection in combination with bevacizumab biosimilar injection resulted in a statistically significant improvement in progression-free survival and overall survival compared with sorafenib in patients with advanced hepatocellular carcinoma.

The European Commission has granted a conditional marketing authorization to avapritinib for single agent use in adult patients with unresectable or metastatic gastrointestinal stromal tumors that harbor a PDGFRA D842V mutation.

A new drug application has been submitted to the FDA for TLX591-CDx, a radiopharmaceutical product that targets prostate-specific membrane antigen, for the imaging of prostate cancer through the use of positron emission tomography.

The Japanese Ministry of Health, Labor, and Welfare has approved the antibody-drug conjugate trastuzumab deruxtecan for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer that has progressed following chemotherapy.

Adjuvant nivolumab was found to result in a significant improvement in disease-free survival compared with placebo in patients with high-risk muscle-invasive urothelial carcinoma, including those whose tumors expressed PD-L1 of 1% or higher, meeting the primary end points of the phase 3 CheckMate-274 trial.

The myelofibrosis paradigm is bursting with novel agents and combinations that have been developed with the ultimate goal of helping patients live longer.

The FDA has granted a fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors have high DKK1 expression, who have progressed on or after a fluoropyrimidine- and platinum-containing chemotherapy, and HER2/neu targeted therapy, if appropriate.

The FDA has granted a priority review to a supplemental new drug application for crizotinib in the treatment of pediatric patients with ALK-positive relapsed/refractory systemic anaplastic large cell lymphoma.

A biologics license application has been submitted to the FDA for loncastuximab tesirine for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

Ivosidenib demonstrated a consistent trend toward improved overall survival compared with placebo in treatment-naïve patients with IDH1-positive cholangiocarcinoma, although the benefit was not determined to be statistically significant.

The FDA has granted a priority review designation to a biologics license application for idecabtagene vicleucel for the treatment of adult patients with multiple myeloma who have received at least 3 previous therapies.

The addition of atezolizumab to a backbone comprised of bevacizumab and chemotherapy failed to significantly improve progression-free survival in patients with newly diagnosed stage III/IV ovarian cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for olaparib as maintenance treatment in adult patients with advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response after first-line platinum-based chemotherapy plus bevacizumab and whose disease has homologous recombination deficiency positivity defined by either a BRCA1/2 mutation and/or genomic instability.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for olaparib for approval as a monotherapy for metastatic castration-resistant prostate cancer and BRCA1/2 mutations who have progressed after previous therapy with a new hormonal agent.

Frontline pembrolizumab plus chemotherapy significantly improved overall survival, progression-free survival, and objective response rates compared with chemotherapy alone in patients with locally advanced unresectable or metastatic esophageal cancer.

Lenvatinib plus pembrolizumab showed early antitumor activity and tolerability in previously treated patients with advanced solid tumors.

Overall survival benefits of frontline maintenance treatment with avelumab in patients with advanced urothelial cancer were found to be positively associated with biomarkers of immune activity and negativity linked with biomarkers of tumor homeostasis and chronic inflammation.

Dostarlimab showcased durable antitumor activity in patients with advanced or recurrent DNA mismatch repair deficient and proficient endometrial cancer, with a notable disease control rate and a promising safety profile.

Sacituzumab govitecan-hziy continued to showcase significant activity with favorable tolerability in heavily pretreated patients with metastatic urothelial carcinoma who progressed on both platinum-based chemotherapy and checkpoint inhibition.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the frontline treatment of patients with metastatic non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for niraparib for frontline maintenance treatment in patients with advanced ovarian cancer who are responsive to platinum-based chemotherapy.

Enfortumab vedotin-ejfv resulted in a significant improvement in overall survival versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.