Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: [email protected]
The FDA has accepted and granted a priority review designation to a supplemental biologics license application for the antibody-drug conjugate trastuzumab deruxtecan for use in patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma.
A supplemental application was submitted to the Japanese Ministry of Health, Labour, and Welfare for Manufacturing and Marketing approval of the combination of cabozantinib plus nivolumab for the treatment of patients with unresectable, advanced, or metastatic renal cell carcinoma.
The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic for 3 targeted therapies: alpelisib in advanced or metastatic breast cancer, rucaparib in advanced ovarian cancer, and alectinib in a specific type of metastatic non–small cell lung cancer.
PLX8394, a next-generation BRAF inhibitor, in combination with cobicistat was found to demonstrate encouraging clinical activity with an acceptable safety profile in patients with BRAF-mutated, refractory solid tumors.
Adagrasib, a potent and selective inhibitor of KRAS G12C, showcased encouraging clinical activity with an acceptable safety profile in patients with KRAS G12C–positive non–small cell lung cancer, colorectal cancer, and other solid tumors.
The novel HER3-targeted antibody-drug conjugate patritumab deruxtecan is currently being investigated in a phase 2 trial as a potential treatment for patients with advanced or metastatic colorectal cancer who are resistant, refractory, or intolerant to at least 2 previous lines of systemic therapy.
Afatinib was found to be effective when used in Asian and non-Asian patients with non–small cell lung cancer with major uncommon and compound EGFR mutations, irrespective of ethnicity.
Afatinib was found to be effective and well tolerated when used as a second-line treatment in patients with metastatic squamous carcinoma of the lung.
The combination of onvansertib plus abiraterone acetate and prednisone achieved disease control in patients with metastatic castration-resistant prostate cancer who had initial resistance to abiraterone.
The FDA has granted osimertinib a priority review designation to a supplemental new drug application for the adjuvant treatment of patients with early-stage EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
Pembrolizumab has demonstrated promising activity when used in combination with chemotherapy or quavonlimab in select patients with nonsquamous or advanced non–small cell lung cancer.
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.
