Roman Fabbricatore

The approval marks Foundation Medicine’s first companion diagnostic indication to exclusively support pediatric patients with brain tumors.

The CRL did not identify any deficiencies related to the manufacturing, efficacy, or safety outlined in the BLA, and no new clinical trials were requested.

Phase 3 EMERALD-1 trial results reveal that no new adverse events were identified with durvalumab plus bevacizumab in patients with unresectable HCC.

The developers expect the product to be available for order in the United States in early February 2025.

Patients in the ponsegromab group had significantly greater weight gain and physical activity than those in the placebo arm in a phase 2 trial.

Nearly half of patients with an ICD had a device programming encounter near the end of life, which could present an opportunity to discuss goals of care.

The decision follows safety data from the phase 1/2 LOKON001 trial evaluating LOAd703 in advanced pancreatic ductal adenocarcinoma.

The World Health Organization has approved emiltatug ledadotin as XMT-1660’s international nonproprietary name.

Efficacy findings reveal that the phase 3 ARES study evaluating MaaT013 met its primary end point of gastrointestinal overall response rate.

Safety data from the phase 2 LITESPARK-003 trial evaluating belzutifan/cabozantinib in renal cell carcinoma show no treatment-related deaths.

The decision was supported by efficacy findings from the phase 1 ONKORAS-101 trial, which evaluated the therapy in KRASG12C non–small cell lung cancer.

Efficacy findings from a phase 2 trial demonstrated that abenacianine visualized lung tumor tissue and was well tolerated when used during surgery.

Results from the phase 3 MARIPOSA trial found that amivantamab plus lazertinib met the final pre-specified secondary end point of overall survival in NSCLC.

According to the FDA, biopsies should be optional in clinical protocol when information will be used to evaluate only non-key secondary end points.

No dose-limiting toxicities were observed with upamostat combination therapy in patients with metastatic pancreatic cancer.

A study observed differences between expected and observed cancer incidence in 2020 and 2021 to evaluate the pandemic’s disruption of cancer detection.

The decision is supported by results from the phase 2 TRUST-1 trial, which evaluated the safety and efficacy of taletrectinib in ROS1-positive NSCLC.

Atezolizumab combination therapy elicited better responses in patients with PD-L1 expression of 1% or more with EGFR-mutant NSCLC.

Gemcitabine plus capecitabine was found to elicit longer survival outcomes than capecitabine alone in patients with pancreatic adenocarcinoma.

A pooled analysis of 2 trials show that psilocybin-assisted psychotherapy may provide mental health benefits for patients with cancer.

Feedback from the European Medicines Agency following results of the phase 3 TROPION-Lung01 informed the marketing authorization application withdrawal.

The SU2C-SARC032 study evaluating pembrolizumab plus radiotherapy and surgery found the regimen was well tolerated with infrequent surgical complications.

Updated efficacy findings from the phase 3 CheckMate-8HW trial also showed fewer grade 3/4 adverse events with nivolumab/ipilimumab vs chemotherapy.

The SU2C-SARC032 study evaluating pembrolizumab plus radiotherapy and surgery found the regimen was well tolerated with infrequent surgical complications.

Data from CheckMate-67T support the approval of subcutaneous nivolumab in patients with solid tumors across all previously approved nivolumab indications.

Data from the RATIONALE 305 trial support the approval of tislelizumab/chemotherapy in unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma.

The first stage of a phase 2 trial evaluating neoadjuvant SHR-A1811 in breast cancer meets its primary end point of ORR.

In the phase 1b/2 FELIX study, obecabtagene autoleucel was associated with low incidence of grade 3 or higher immune-related toxicity.

Data from the phase 3 eXalt3 trial support the approval of ensartinib in adult patients with metastatic ALK-positive non–small cell lung cancer.