Kristi Rosa

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.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that idecabtagene vicleucel receive conditional marketing authorization for use in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and a CD38-targeted antibody, and have progressed on their last therapy.

The FDA has granted a breakthrough therapy designation to adagrasib for use as a potential therapeutic option for patients with KRAS G12C–mutated non–small cell lung cancer following previous systemic therapy.

The addition of sintilimab to chemotherapy significantly improved overall survival over chemotherapy alone when used as a first-line treatment in patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma, meeting the primary end point of the phase 3 ORIENT-15 trial.

The Chinese National Medical Products Administration has granted conditional approval to olaparib for use as a monotherapy in the treatment in adult patients with germline or somatic BRCA-mutated, metastatic castration-resistant prostate cancer who have progressed after previous treatment that included a new hormonal agent like abiraterone acetate or enzalutamide.

The anti-TIGIT agent domvanalimab in combination with zimberelimab with or without etrumadenant demonstrated promising objective response rates when given as a first-line treatment in patients with metastatic non–small cell lung cancer who have a PD-L1 expression of 50% or higher.

The next-generation CD37-directed radioimmunotherapy 177Lu lilotomab satetraxten has showcased early clinical activity with favorable tolerability when used in patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for stem cell transplantation.

Individuals with cancer or who have a history of cancer should qualify for inclusion on COVID-19 vaccine trials, unless there is a safety justification for exclusion.

Savolitinib has been granted a conditional approval in China for use in patients with non–small cell lung cancer with MET exon 14 skipping alterations who experienced disease progression after previous systemic therapy or are unable to receive chemotherapy.

Loncastuximab tesirine-lpyl continued to demonstrate promising antitumor activity with an acceptable toxicity profile when used in the treatment of select patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma.