Kristi Rosa

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.

The European Medicines Agency has validated a Type II Variation for nivolumab in combination with ipilimumab as a frontline treatment for previously untreated patients with unresectable malignant pleural mesothelioma.

The FDA has approved the expanded use of the CINtec PLUS Cytology assay for women who undergo cervical cancer screening and test positive for high-risk types of human papillomavirus.

The bispecific antibody CDX-527 is now under investigation in patients with advanced or metastatic solid tumors who have progressed during or following standard-of-care treatment with the recent initiation of a open-label phase 1 trial.

The FDA has granted a breakthrough therapy designation to magrolimab for the treatment of patients with newly diagnosed myelodysplastic syndrome.

Investigators are evaluating the clinical and immunological impact of the experimental, engineered fusion protein ALKS 4230 on the tumor microenvironment of several advanced, malignant solid tumors in the recently initiated phase 2 ARTISTRY-3 trial.

The FDA granted a fast track designation to the highly-selective N-terminal domain inhibitor EPI-7386 for the treatment of adult patients with metastatic castration-resistant prostate cancer who are resistant to standard-of-care options.

The wellbeing and job performance of oncology professionals has been significantly impacted by the COVID-19 pandemic, and although the extent of this impact is varied between countries, it has been suggested to be related to the crude mortality rate of the virus.

The first patient has been enrolled on the phase 2 portion of the LIO-1 trial, which will examine the combination of lucitanib plus nivolumab in those with gynecologic cancers.

Although the addition of ixazomib to lenalidomide and dexamethasone showed an improvement in progression-free survival in patients with newly diagnosed multiple myeloma who are not candidates for autologous stem cell transplant, it was not determined to be of statistical significance.

The novel anti-folate receptor alpha antibody-drug conjugate STRO-002 demonstrated encouraging efficacy with a tolerable safety profile in patients with advanced platinum-resistant or refractory epithelial ovarian cancer.