Kristi Rosa

Tesetaxel in combination with a reduced dose of capecitabine led to a significant improvement in progression-free survival versus the approved dose of capecitabine alone, meeting the primary end point of the phase 3 CONTESSA trial.

The Japan Pharmaceuticals and Medical Devices Agency has approved pembrolizumab for the treatment of patients with radically unresectable, advanced, or recurrent esophageal squamous cell carcinoma whose tumors are PD-L1–positive, and at an additional recommended dosage of 400 mg every 6 weeks as an intravenous infusion across all adult indications.

Intravenous rigosertib did not meet the primary end point of significantly improved overall survival versus physician’s choice of therapy plus best supportive care in patients with higher-risk myelodysplastic syndromes.

Spartalizumab in combination with dabrafenib and trametinib failed to meet the primary end point of investigator-assessed progression-free survival in treatment-naïve patients with unresectable or metastatic BRAF V600 mutation–positive cutaneous melanoma.

The FDA has approved daratumumab in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy.

The European Commission has granted a marketing authorization to Aybintio, a bevacizumab biosimilar for the treatment of patients with the same types of cancer for which the reference product is indicated in the European Union.

The FDA has granted a fast track designation to paxalisib for the treatment of patients with glioblastoma.

Treatment with repotrectinib resulted in favorable responses in patients with ROS1- or NTRK-driven tumors, regardless of prior treatment with TKIs, according to interim data from the phase 2 TRIDENT-1 trial.

Pembrolizumab in combination with chemotherapy significantly improved overall survival and progression-free survival in the frontline treatment of patients with locally advanced or metastatic esophageal cancer.

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

The FDA has granted a priority review designation to a supplemental biologics license application for a new 4-week, fixed-dose regimen as treatment in approved indications of non–small cell lung cancer and bladder cancer.

A panel of experts discuss some of the encouraging data on emerging modalities in melanoma presented during the 2020 ASCO Virtual Scientific Program and share how they might apply that information to clinical practice.

The FDA has granted a priority review designation to a new drug application (NDA) for trilaciclib for the treatment of patients with small cell lung cancer (SCLC) who are being treated with chemotherapy.

The combination of dabrafenib and trametinib elicited favorable response rates in a mixed histology cohort of pretreated patients with solid tumors, lymphomas, and multiple myeloma whose tumors harbored a BRAF V600 mutation.

The FDA’s Oncologic Drugs Advisory Committee voted 8 to 2 in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

Debio 1143 in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy was found to induce a statistically and clinically significant improvement in overall survival compared with CRT alone in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.

The independent data safety monitoring committee has unanimously recommended that the phase 3 OVAL trial examining VB-111 in patients with platinum-resistant ovarian cancer continue as planned.

Nivolumab in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma

Nivolumab, following neoadjuvant chemoradiation and complete surgical resection, resulted in a statistically significant improvement in disease-free survival in patients with resected esophageal or gastroesophageal junction cancer.

The FDA has issued a complete response letter to Fennec Pharmaceuticals regarding its new drug application for a unique formulation of sodium thiosulfate (Pedmark) for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.

Treatment with afatinib followed by osimertinib resulted in a median overall survival benefit of almost 4 years in US patients with EGFR T790M–positive non–small cell lung cancer in the real-world setting.

The anti–PD-L1 monoclonal antibody CS1001 in combination with platinum-based chemotherapy led to a significant improvement in progression-free survival when used as a frontline treatment for patients with stage IV squamous and nonsquamous non–small cell lung cancer.

Ensartinib showed a significant improvement in progression-free survival over crizotinib with a favorable safety profile in patients with ALK-positive non–small cell lung cancer.

The FDA has granted a priority review designation to a new drug application for a unique formulation of sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in patients from 1 month to less than 18 years of age with localized, nonmetastatic, solid tumors.

The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.

Atezolizumab in combination with paclitaxel did not demonstrate a statistically significant improvement in progression-free survival as a first-line treatment for patients with PD-L1–positive triple-negative breast cancer, failing to meet the primary end point of the IMpassion131 trial.

A CD30-targeted CAR T-cell therapy was found to elicit a high rate of durable complete responses (CRs) in heavily pretreated patients with relapsed/refractory Hodgkin lymphoma.

The FDA has cleared the clonoSEQ® assay to identify and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.

The biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for use in pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma has been submitted to the FDA under the agency’s Rolling Review process.

Lorlatinib significantly improved progression-free survival in treatment-naive patients with advanced ALK-positive non–small cell lung cancer versus crizotinib, meeting the primary end point of the phase 3 CROWN trial.