Kristi Rosa

The European Medicines Agency has validated a Marketing Authorization application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who had previously received at least 2 therapies, including at least 1 therapy for locally advanced or metastatic disease.

The European Medicines Agency has accepted a marketing authorization application for enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant or adjuvant, locally advanced or metastatic setting.

Palbociclib in combination with endocrine therapy resulted in improved survival outcomes in a real-world population of patients with hormone receptor–positive, HER2-negative, metastatic breast cancer vs letrozole alone in the first-line setting.

The FDA has granted 2 breakthrough device designations to cover new intended uses of the Signatera molecular residual disease test developed by Natera, Inc.

The Japanese Ministry of Health, Labour, and Welfare has approved pemigatinib for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening following chemotherapy.

The addition of the targeted radioligand therapy 177Lu-PSMA-617 to best standard of care was found to significantly improve overall survival and radiographic progression-free survival over best standard care alone in patients with prostate specific membrane antigen–positive metastatic castration-resistant prostate cancer, meeting both primary end points of the phase 3 VISION trial.

The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.

Olaparib, when used in patients with platinum-sensitive relapsed ovarian cancer who had a known BRCA mutation and homologous recombination deficiency status, demonstrated adverse effects that proved to be consistent with the established safety profile of the PARP inhibitor.

The PD-L1 inhibitor atezolizumab was found to improve disease-free survival over best supportive care when used as an adjuvant treatment in patients with PD-L1–positive, stage II-IIIA non–small cell lung cancer, meeting the primary end point of the phase 3 IMpower010 trial.

Key updates to the National Comprehensive Cancer Network guidelines for gastric and esophageal cancers include the incorporation of immune checkpoint inhibitors spanning settings in patients with gastroesophageal cancer, the inclusion of fam-trastuzumab deruxtecan-nxki for those with HER2-positive gastric cancer, and the addition of recommended ramucirumab combinations for use in second- or later-line settings.

The combination of tilsotolimod plus ipilimumab failed to improve objective response rate over ipilimumab alone in patients with advanced melanoma who are refractory to a PD-1 inhibitor, missing the primary end point of the phase 2 ILLUMINATE-301 trial.

The trispecific killer cell engager product GTB-3550 was found to result in up to a 63.7% reduction in bone marrow blast levels in patients with high-risk myelodysplastic syndromes and relapsed/refractory acute myeloid leukemia.

The European Commission has approved an expanded label for pembrolizumab for use as a single agent in the treatment of select adult and pediatric patients aged 3 years and older who have relapsed/refractory classical Hodgkin lymphoma.

Single-agent bintrafusp alfa demonstrated efficacy, durability, and an acceptable toxicity profile when used in patients with locally advanced or metastatic biliary tract cancer who have progressed on or are intolerant of frontline platinum-based chemotherapy.

The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.

Axicabtagene ciloleucel elicited a high objective response rate of 85%, with a complete response rate of 74% when used as a first-line therapy in patients with high-risk large B-cell lymphoma.

The FDA has issued a complete response letter regarding the biologics license application for ropeginterferon alfa-2b-njft for the treatment of patients with polycythemia vera.

A phase 3 trial evaluating single-agent cemiplimab will be stopped early due to positive results demonstrating an overall survival benefit over chemotherapy in patients with recurrent or metastatic cervical cancer who previously received chemotherapy.

The FDA has granted a fast track designation to poziotinib for use in previously treated patients with HER2 exon 20 mutations.

The FDA has extended the review period for the new drug application for belumosudil for use in patients with chronic graft-versus-host disease to allow for more time to review additional data submitted by the biopharmaceutical company.

The FDA has granted an orphan drug designation to the orally bioavailable, highly-specific G protein-coupled estrogen receptor agonist LNS8801 for the treatment of patients with metastatic uveal melanoma.

One in 7 Caribbean-born individuals with either breast or ovarian cancer had hereditary disease with an actionable pathogenic variant, which provides the opportunity for the utilization of targeted therapeutics and precise prevention strategies.

Interferon-alpha has been shown to significantly improve both myelofibrosis-free survival and overall survival over hydroxyurea and phlebotomy only in patients with polycythemia vera.

The combination of canakinumab plus docetaxel failed to significantly improve overall survival in patients with locally advanced or metastatic non–small cell lung cancer whose disease has progressed while on, or after, prior platinum-based chemotherapy and a PD-L1 agent, missing the primary end point of the phase 3 CANOPY-2 trial.

The FDA has approved the VENTANA ALK CDx assay as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who are eligible to receive treatment with lorlatinib.

The United Kingdom’s National Institute for Health and Care Excellence will not recommend olaparib for the treatment of patients with hormone-relapsed, metastatic prostate cancer that harbors BRCA1 or BRCA2 mutations that has progressed on abiraterone acetate or enzalutamide.

Roche has withdrawn atezolizumab from the US market for the treatment of patients with metastatic urothelial carcinoma who had previously received platinum-based therapy.

One year into the COVID-19 pandemic has allowed for some reflection on the different evolutions that the oncology community went through in response to the many challenges posed by the virus.

The FDA has granted an accelerated approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory indolent follicular lymphoma after 2 or more lines of systemic therapy.

The FDA has granted an orphan drug designation to cavrotolimod for the treatment of patients with Merkel cell carcinoma.