Kristi Rosa

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend an additional indication of enzalutamide for the treatment of adult patients with metastatic hormone-sensitive prostate cancer.

The FDA has issued a complete response letter to Merck stating that regulatory decision for the supplemental biologics license application seeking approval for pembrolizumab for use in patients with high-risk, early-stage triple-negative breast cancer plus chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant treatment following surgery, should be deferred.

The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

The rolling submission of a biologics license application to support the approval of ublituximab plus umbralisib as a treatment for patients with chronic lymphocytic leukemia has been completed.

Osimertinib (Tagrisso) showcased encouraging efficacy and acceptable safety in patients with EGFR-positive, advanced non–small cell lung cancer. according to real-world findings from an observational, multicenter study.

Previous exposure to immune checkpoint inhibitors or osimertinib has been linked with poor outcomes in patients with non–small cell lung cancer who were receiving a subsequent atezolizumab-containing regimen.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.

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.