Kristi Rosa

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.

The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to identify patients with RET fusion–positive non¬–small lung cancer who are candidates to receive the recently approved targeted therapy pralsetinib.

The European Commission has approved an expanded indication of ibrutinib for use in combination with rituximab in treatment-naïve adult patients with chronic lymphocytic leukemia.

The China National Medical Products Administration has approved niraparib for use as a first-line maintenance treatment in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieve a complete or partial response to first-line platinum-based chemotherapy.

The FDA has granted a breakthrough therapy designation to plinabulin for chemotherapy-induced neutropenia.

A supplemental biologics license application has been submitted to the FDA for daratumumab plus hyaluronidase-fihj for the treatment of patients with amyloid light chain amyloidosis.

The first-in-class radioiodinated phospholipid drug conjugate CLR 131 elicited a clinically meaningful overall response rate of 40% in patients with triple-class refractory multiple myeloma who received a total administered dose of 60 mCi or greater.

The FDA has approved copper Cu 64 dotatate injection for the localization of somatostatin receptor–positive neuroendocrine tumors.

The FDA has issued an alert that the phase 3 IMpassion131 trial failed to show the effectiveness of atezolizumab plus paclitaxel in treatment-naïve patients with inoperable locally advanced or metastatic triple-negative breast cancer.