Kristi Rosa

The FDA has lifted a partial clinical hold that was placed on a first-in-human, phase 1b trial evaluating RVU120 in patients with relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

The combination of bempegaldesleukin plus nivolumab continued to produce promising antitumor activity with favorable tolerability when used in the frontline treatment of patients with metastatic melanoma, according to findings from a phase 2 cohort of the phase 1/2 PIVOT-2 trial.

The FDA has granted a fast track designation to berubicin as a potential therapeutic option for patients with recurrent glioblastoma multiforme.

The FDA has approved daratumumab plus hyaluronidase-fihj (Darzalex Faspro) plus pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor

The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma and head and neck cancer.

Patients with a urological cancer who were also infected with COVID-19 and undergoing elective surgery for their disease, were found to have a significantly higher likelihood of experiencing respiratory complications and mortality than those without the virus.

The FDA has granted a regular approval to enfortumab vedotin-ejfv and has expanded the agent's indication to include adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and who have received 1 or more prior lines of therapy.

The combination of INN melphalan flufenamide and dexamethasone was found to induce a superior progression-free survival benefit over pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma who had previously received 2 to 4 lines of therapy, meeting the primary end point of the phase 3 OCEAN trial.

The investigational RNA interference therapy, ARO-HIF2, was shown to have encouraging signals of activity with favorable tolerability in heavily pretreated patients with advanced clear cell renal cell carcinoma.

The tumor-infiltrating lymphocyte therapy LN-145 was found to induce an objective response rate of 21.4% in patients with advanced or metastatic non–small cell lung cancer who had progressed following systemic therapy.

The novel combination comprised of rigosertib and nivolumab showed preliminary evidence of potential anticancer activity in patients with advanced metastatic KRAS-mutated non–small cell lung cancer.

Athenex, Inc. held a Type A meeting with the FDA to discuss the deficiencies raised in the complete response letter issued in March 2021 for the new drug application for oral paclitaxel plus encequidar in the treatment of patients with metastatic breast cancer.

Merck has announced plans to withdraw the accelerated approval indication for pembrolizumab in the treatment of select patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express a PD-L1 combined positive score of 1 or more, and who have progressed on or after 2 or more previous lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy, and HER2-/neu-targeted therapy, if appropriate.

The FDA has expanded the label for pembrolizumab for use as a monotherapy in the treatment of patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

An independent data monitoring committee has recommended that the phase 3 ARMADA 200 trial examining devimistat plus high-dose cytarabine and mitoxantrone in patients with relapsed or refractory acute myeloid leukemia continue as planned.

The FDA has approved FoundationOne CDx for use as a companion diagnostic for brigatinib, which was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer.

The FDA has approved a labeling supplement to the US prescribing information for neratinib that includes the dose-escalated use of the agent in patients with HER2-positive breast cancer, as examined in the phase 2 CONTROL trial, and the new 133-count commercial Nerlynx SKU.

The FDA has accepted the filing of the new drug application for surufatinib as a potential therapeutic option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

The combination of the GAS6/AXL inhibitor AVB-500 and cabozantinib has demonstrated acceptable tolerability when used in the treatment of patients with clear cell renal cell carcinoma.

The immunotherapy Leukocyte interleukin followed by surgery and radiotherapy, without chemotherapy, significantly improved overall survival compared with standard of care alone in the treatment of patients with advanced primary squamous cell carcinoma of the head and neck.

The European Commission has approved the combination of nivolumab plus ipilimumab for use in adult patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following previous fluoropyrimidine-based combination chemotherapy.

The European Commission has approved pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma whose tumors have PD-L1 expression.

The combination of balixafortide and eribulin did not significantly improve objective response rate over eribulin alone in the treatment of patients with HER2-negative, locally recurrent or metastatic breast cancer, missing the co-primary end point of the phase 3 FORTRESS study.

The FDA has granted a breakthrough therapy designation orelabrutinib for the treatment of patients with relapsed/refractory mantle cell lymphoma.

The combination of the targeted cancer vaccine galinpepimut-S plus nivolumab resulted in a median overall survival of 35.4 weeks in patients with macroscopic deposits of malignant pleural mesothelioma who had received treatment for at least 1 month.

Axicabtagene ciloleucel significantly improved event-free survival by 60% over chemotherapy plus stem cell transplant in the second-line treatment of patients with relapsed or refractory large B-cell lymphoma, meeting the primary end point of the phase 3 ZUMA-7 trial.

The combination of cabozantinib and atezolizumab was found to significantly improve progression-free survival compared with sorafenib when used in the first-line treatment of patients with advanced hepatocellular carcinoma, meeting a primary end point of the phase 3 COSMIC-312 trial.

The FDA has issued an emergency use authorization for intravenous tocilizumab for the treatment of adult and pediatric patients who have been hospitalized, are receiving systemic corticosteroids, and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after previous neoadjuvant chemoradiotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion in favor of granting conditional marketing authorization to the combination of tafasitamab-cxix and lenalidomide, followed by single-agent tafasitamab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.