Kristi Rosa

The FDA has granted priority review to a supplemental biologics license application for the combination of nivolumab and chemotherapy in the neoadjuvant treatment of patients with resectable non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the use of nivolumab in combination with chemotherapy in the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for use as an adjuvant treatment in adult patients with muscle-invasive urothelial carcinoma with a PD-L1 expression of at least 1% on tumor cells, who are at a high risk of recurrence following radical resection.

The novel androgen receptor PROTAC degrader, bavdegalutamide, was found to be clinically active and tolerable with manageable adverse effects in patients with metastatic castration-resistant prostate cancer.

Sotorasib had clinically meaningful activity in heavily pretreated patients with KRAS G12C–mutated advanced pancreatic cancer, according to findings from the phase 1/2 CodeBreaK 100 trial.

The European Medicines Agency has accepted for review 2 new indication applications for zanubrutinib as a therapeutic option for patients with chronic lymphocytic leukemia and for those with marginal zone lymphoma.

The FDA has accepted for review a supplemental new drug application for zanubrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The Data Safety Monitoring Board for the ongoing phase 1/2 OVATION 2 trial has unanimously recommended that patients continue to receive treatment with the novel gene-mediated immunotherapy, GEN-1, at a dose of 100 mg/m2.

The FDA has given the green light to the FoundationOne CDx for use as a companion diagnostic that can be leveraged to identify patients with microsatellite instability high solid tumors who may be candidates to receive and derive benefit from pembrolizumab.

The European Commission has approved tepotinib for use as a single agent in adult patients with advanced non–small cell lung cancer harboring METex14 skipping alterations who require systemic therapy after prior treatment with immunotherapy and/or platinum-based chemotherapy.

Trastuzumab deruxtecan resulted in a statistically significant improvement in progression-free survival and overall survival compared with physician’s choice of chemotherapy in patients with HER2-low unresectable and/or metastatic breast cancer, irrespective of hormone receptor status, meeting the primary and secondary end points of the phase 3 DESTINY-Breast 04 trial.

The addition of olaparib to durvalumab did not result in a significant prolongation in progression-free survival compared with durvalumab alone in patients with previously untreated, platinum-ineligible metastatic urothelial carcinoma.

The FDA has granted a fast track designation to IO-202, a first-in-class anti-LILRB4 myeloid checkpoint inhibitor, as a potential therapeutic option for patients with relapsed or refractory acute myeloid leukemia.

The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of the CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma in whom frontline therapy has failed.

The FDA has placed a clinical hold on a phase 1 trial evaluating the safety and efficacy of the autologous CAR T-cell product LB1901 as a potential therapeutic option in adult patients with relapsed or refractory T-cell lymphoma.

The FDA has accepted a new drug application for the use of adagrasib in the treatment of patients with non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have previously received at least 1 prior systemic therapy.

The FDA has granted a breakthrough device designation to the TriNetra-Prostate blood test for use in the detection of early-stage prostate cancer.

The FDA has accepted for review a new drug application for poziotinib in patients with previously treated locally advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations.

The novel non-viral gene therapy, EG-70, produced a complete response rate of 83% at 3 months in evaluable patients with high-grade non–muscle invasive bladder cancer with carcinoma in situ who were unresponsive to Bacillus Calmette-Guérin.

Induction treatment with ibrutinib and rituximab was safe and active in patients with mantle cell lymphoma aged 65 years or younger, allowing for fewer cycles of subsequent chemotherapy with rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone thereby reducing toxicity.

With 9 approved markers in non–small cell lung cancer and a plethora of established and emerging therapies that have been designed to target them, the need for molecular testing is more important than ever.

Lyudmila Bazhenova, MD, explores key challenges faced with diagnosing and appropriately treating patients with non–small cell lung cancer that harbors EGFR exon 20 insertion mutations and provides insight into the second-line options that have recently garnered regulatory approval.

Frontline maintenance treatment with selinexor resulted in a statistically significant improvement in median progression-free survival vs placebo in patients with advanced or recurrent endometrial cancer, meeting the primary end point of the phase 3 SIENDO trial.

Antibody-drug conjugates appear to have the most activity in those with non–small cell lung cancer and HER2 expression.

The FDA has announced that they are investigating umbralisib (Ukoniq), an oral inhibitor of PI3K-delta and CK1-epsilon that is approved to treat patients with marginal zone lymphoma and follicular lymphoma, after initial data from the phase 3 UNITY-CLL trial revealed a potential increased risk of death in those who received the agent.

The 3-patient safety run-in for the pancreatic cancer cohort of the ongoing phase 1/2 GOBLET study did not reveal any safety concerns with the novel combination of pelareorep and atezolizumab.

The combination of brentuximab vedotin and chemotherapy resulted in a statistically significant improvement in overall survival when used in the frontline treatment of patients with advanced classical Hodgkin lymphoma.

The submission of a supplemental biologics license application seeking the approval of a Monday/Wednesday/Friday intramuscular dosing schedule for asparaginase erwinia chrysanthemi-rywn for use as a component of a multiagent chemotherapy regimen in patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to Escherichia coli–derived asparaginase has been submitted to the FDA.

The FDA has granted a rare pediatric disease designation to the bone-targeting radiopharmaceutical, Samarium-153-DOTMP, for use as a potential therapeutic option for patients with osteosarcoma.