Chris Ryan

The FDA has granted priority review to the biologics license application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.

Treatment with the interleukin-12 gene-mediated immunotherapy IMNN-001 in combination with neoadjuvant platinum chemotherapy led to an improvement in progression-free survival compared with neoadjuvant chemotherapy alone in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

First-line treatment with the combination of amivantamab and lazertinib resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.

Treatment with the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone generated high rates of minimal residual disease negativity in patients with newly diagnosed, high-risk multiple myeloma, irrespective of transplant status.

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy.

The FDA has granted fast track designation to ABM-1310 for the treatment of patients with glioblastoma harboring BRAF V600E mutations.

The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and PARP inhibitor therapies.

First-line treatment with lutetium Lu 177 dotatate plus long-acting octreotide led to a statistically significant and clinically meaningful improvement in progression-free survival compared with high-dose long-acting octreotide alone in newly diagnosed patients with somatostatin receptor–positive, grade 2 and 3, advanced gastroenteropancreatic neuroendocrine tumors.

The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.

Treatment with the combination of enfortumab Vedotin and pembrolizumab led to an improvement in overall survival and progression-free survival compared with chemotherapy in previously untreated patients with locally advanced or metastatic urothelial cancer who were eligible for cisplatin- or carboplatin-containing chemotherapy.

Neoadjuvant treatment with nivolumab plus platinum-based chemotherapy, followed by surgery and adjuvant nivolumab monotherapy, generated a statistically significant and clinically meaningful improvement in event-free survival vs neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant placebo, in patients with resectable stage IIA to IIIB non–small cell lung cancer.

Treatment with SLS009 generated clinical activity and was safe in patients with relapsed/refractory lymphomas.

The FDA has granted priority review to a supplemental biologics license application seeking the approval of pembrolizumab in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy, for the treatment of newly diagnosed patients with high-risk, locally advanced cervical cancer.

The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

The European Commission has approved oral decitabine and cedazuridine for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for standard induction chemotherapy.

The FDA has granted priority review to the supplemental new drug application seeking the approval of belzutifan for the treatment of previously treated patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies.

The FDA has granted fast track designation to KT-333 for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against renewal of the conditional marketing authorization for belantamab mafodotin-blmf for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

The FDA has extended the priority review period for the biologics license application seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.

The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma. Under Project Renewal, the regulatory agency has also revised indications for the treatment of patients with refractory anaplastic astrocytoma.

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of golidocitinib for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer.

Neoadjuvant treatment with the combination of nivolumab and ipilimumab led to responses and was well tolerated in patients with resectable hepatocellular carcinoma.

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.

A rolling new drug application seeking the approval of tovorafenib monotherapy for the treatment of patients with relapsed or progressive pediatric low-grade glioma has been submitted to the FDA.

The FDA has approved motixafortide (Aphexda) in combination with filgrastim (Neupogen) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous stem cell transplant in patients with multiple myeloma.

Treatment with tisotumab vedotin-tftv monotherapy led to an improvement in overall survival compared with chemotherapy alone in patients with recurrent or metastatic cervical cancer that progressed on or after frontline therapy.

Adjuvant treatment with alectinib generated a statistically significant and clinically meaningful improvement in disease-free survival compared with platinum-based chemotherapy in patients with completely resected stage IB to IIIA, ALK-positive non–small cell lung cancer.