Kristi Rosa

The European Union has approved olaparib for use in patients with metastatic castration-resistant prostate cancer who harbor BRCA1/2 mutations.

Single-agent selinexor resulted in a statistically significant prolongation of progression-free survival in patients with advanced unresectable dedifferentiated liposarcoma, meeting the primary end point of the phase 3 SEAL trial.

The FDA has lifted the clinical hold placed on the phase 1 PSMA-101-001 study of the CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

The European Commission has approved the combination of atezolizumab plus bevacizumab for use in adult patients with advanced or unresectable hepatocellular carcinoma who have not been given previous systemic therapy.

The FDA has approved the cobas EGFR Mutation Test v2 as a companion diagnostic for EGFR TKIs in the treatment of patients with EGFR-mutated non–small cell lung cancer.

The China National Medical Products Administration has approved the combination of atezolizumab plus bevacizumab for use in patients with unresectable hepatocellular carcinoma who have not received previous systemic therapy.

The European Commission has approved niraparib for use as a frontline monotherapy maintenance option in adult patients with advanced epithelial, high-grade ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response after platinum-based chemotherapy.

The FDA has granted a priority review designation to a supplemental biologics license application for cemiplimab-rwlc for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer with a PD-L1 expression of 50% or greater.

The addition of anti–PD-1/PD-L1 to combination BRAF and MEK inhibition has been shown to improve progression-free survival and duration of response in patients with BRAF-mutated melanoma, suggesting potential to overcome resistance to targeted approaches.

Delaying treatment for up to 7 days so that genomic data can be utilized to inform a personalized treatment approach is safe, feasible, and can improve overall survival in patients with acute myeloid leukemia.

The use of advanced molecular imaging with the PET radiotracer fluciclovine (18F) to inform treatment decisions can lead to improved disease-free survival rates in patients with recurrent prostate cancer.

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.