Kristi Rosa

The FDA has granted a priority review designation to a supplemental biologics license application and supplemental new drug application for nivolumab plus cabozantinib for the treatment of patients with advanced renal cell carcinoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for KTE-X19 as a treatment in adult patients with relapsed/refractory mantle cell lymphoma who previously received 2 or more lines of systemic therapy, including a BTK inhibitor.

The United Kingdom’s National Institute for Health and Care Excellence has recommended isatuximab-irfc in combination with pomalidomide and dexamethasone as a treatment option for select patients with relapsed/refractory multiple myeloma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for nivolumab in the treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma following previous fluoropyrimidine- and platinum-based chemotherapy.

The FDA has granted regular approval to venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine for patients with newly diagnosed acute myeloid leukemia who are 75 years or older or who have comorbidities precluding intensive induction chemotherapy.

Guadecitabine failed to result in a statistically significant improvement in overall survival compared with physician’s choice of alternative therapy in previously treated adult patients with acute myeloid leukemia and myelodysplastic syndromes or chronic myelomonocytic leukemia.

The FDA has approved an expanded label for pembrolizumab for use as a monotherapy in the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma and pediatric patients with refractory classical Hodgkin lymphoma, or classical Hodgkin lymphoma that has relapsed after 2 or more lines of therapy.

The addition of sipuleucel-T to the androgen-receptor signaling pathway inhibitors abiraterone acetate or enzalutamide reduced the risk of death by 41% and extended median overall survival by 14.5 months in patients with metastatic castration-resistant prostate cancer, irrespective of treatment order.

Copanlisib in combination with rituximab prolonged progression-free survival in patients with non-Hodgkin lymphoma who relapsed following 1 or more previous lines of rituximab-based therapy.

A rolling submission of a new drug application for the JAK2/FLT3 inhibitor pacritinib has been initiated for patients with myelofibrosis and severe thrombocytopenia defined as platelet counts of less than 50,000 μL.

Higher levels of blood tumor involvement were linked with more favorable outcomes in patients who received treatment with mogamulizumab compared with vorinostat in patients with 2 types of cutaneous T-cell lymphoma.

Enfortumab vedotin elicited durable responses in patients with locally advanced or metastatic urothelial cancer who received previous treatment with a PD-1/PD-L1 inhibitor, have not been given a platinum-containing chemotherapy, and are not eligible for cisplatin.

Avatrombopag failed to meet the composite primary end point of avoiding platelet transfusions, chemotherapy dose reductions by 15% or greater, and chemotherapy dose delays by 4 days or more in patients with solid tumors and chemotherapy-induced thrombocytopenia.

Palbociclib was not found to significantly improve invasive disease-free survival in patients with hormone receptor–positive, HER2-negative early breast cancer who had residual disease following neoadjuvant chemotherapy.

The FDA has granted an orphan drug designation and rare pediatric disease designation to the bispecific antibody nivatrotamab for the treatment of patients with neuroblastoma.

The combination of nivolumab plus chemotherapy resulted in a statistically significant improvement in pathologic complete response when used as neoadjuvant treatment in patients with resectable non–small cell lung cancer, meeting the primary end point of the phase 3 CheckMate-816 trial.

Neratinib was shown to have a numerical overall survival benefit in addition to improvements in invasive disease-free survival and central nervous system recurrence in patients with HER2-positive, hormone receptor–positive, early stage breast cancer.

The investigational advanced cell therapy omidubicel resulted in rapid platelet engraftment and reduced the number of infections and hospitalizations in patients with high-risk hematologic malignancies, meeting all 3 secondary end points of a phase 3 trial.

Sotorasib demonstrated durable responses in patients with KRAS G12C–mutated advanced non–small cell lung cancer who had progressed on a median of 2 previous lines of treatment.

The FDA has issued a Refusal to File letter regarding the biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

The FDA has granted a breakthrough therapy designation to IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm.

The immunotherapy combination of adjuvant nivolumab and ipilimumab failed to lead to a statistically significant improvement in recurrence-free survival in the intent-to-treat population of patients with resected stage IIIB/C/D or stage IV melanoma.

The novel somatostatin analog for the Targeted Alpha-emitter Therapy 212Pb-DOTAMTATE has demonstrated early efficacy and a tolerable safety profile in a small cohort of patients with metastatic somatostatin receptor–expressing neuroendocrine tumors irrespective of location of the primary tumor.

Retreatment with Lutathera-based peptide receptor radionuclide therapy has been shown to have an encouraging survival benefit with an acceptable safety in patients with neuroendocrine tumors.

The FDA has issued a complete response letter to Mesoblast Limited regarding a biologics license application for remestemcel-L, recommending that at least 1 additional randomized, controlled study be conducted in adult and/or pediatric patients to provide further evidence of the efficacy of the agent in steroid-refractory acute graft-versus-host disease.

An agreement has been reached to submit a new drug application for the potential accelerated approval of the JAK2/FLT3 inhibitor pacritinib for use in patients with myelofibrosis and severe thrombocytopenia.

Relugolix was not found to achieve statistical superiority with regard to castration resistance–free survival versus leuprolide acetate in patients with metastatic prostate cancer through 48 weeks.

Final data from the pivotal phase 3 ARAMIS trial with darolutamide and androgen deprivation therapy showed that the combination continued to demonstrate a statistically significant improvement in overall survival versus ADT alone in patients with nonmetastatic, castration-resistant prostate cancer.

Frontline sintilimab injection in combination with bevacizumab biosimilar injection resulted in a statistically significant improvement in progression-free survival and overall survival compared with sorafenib in patients with advanced hepatocellular carcinoma.

The European Commission has granted a conditional marketing authorization to avapritinib for single agent use in adult patients with unresectable or metastatic gastrointestinal stromal tumors that harbor a PDGFRA D842V mutation.