Sabrina Serani

A Prescription Drug User Fee Act target action date of February 17, 2025, has been set for a decision on the vimseltinib application.

The FDA-approved regimen is for neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab in patients with resectable non–small cell lung cancer.

Findings from the phase 3 E1910 study showed that blinatumomab extended overall survival when added to chemotherapy vs chemotherapy alone in B-cell precursor acute lymphoblastic leukemia.

Durvalumab was also granted breakthrough therapy designation for the treatment of patients with limited-stage small cell lung cancer.

A phase 1b study will investigate PTM-101, a directed administration of paclitaxel, in patients with nonmetastatic pancreatic cancer.

Moritz Fürstenau, MD, discussed a follow-up of the GAIA/CLL13 study exploring venetoclax combinations vs chemoimmunotherapy for the treatment of chronic lymphocytic leukemia.

Selpercatinib led to high response and progression-free survival rates among patients who were treatment naive and pretreated with RET-altered thyroid cancers.

Erin E. Hahn, PhD, MPH, discussed the findings and implications of a retrospective study exploring breast cancer surveillance in pre- and post-COVID periods.

The blood-based ctDNA test delivered high rates of sensitivity and specificity with long lead times in detecting minimal residual disease in patients with colorectal cancer.

A phase 2 study found that a combination of pacritinib, sirolimus, and tacrolimus successfully suppressed pSTAT3 and Th1/Th17 cells, but failed to prevent acute graft-versus-host disease following allogeneic transplant.

Isatuximab plus VRd induction before transplant led to better progression-free survival compared with VRd alone, according to data from the GMMG-HD7 phase 3 study.

KeyVibe-008, a phase 3 study investigating the combination of vibostolimab and pembrolizumab in small cell lung cancer, did not show an improvement in overall survival.

The study will evaluate silmitasertib, a novel agent, for the treatment of pediatric and adult patients with relapsed/refractory solid tumors.

Following voluntary withdrawal in 2014, denileukin diftitox is now available again for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

The FDA has set a target action date of April 3, 2025, for the supplemental new drug application of cabozantinib for the treatment of neuroendocrine tumors.

LP-300, a novel small molecule, shows promise as a potential breakthrough treatment for advanced non–small cell lung cancer in never smokers.

Suresh S. Ramalingam, MD, discussed the practice-changing findings and implications of the phase 3 LAURA study investigating osimertinib for the treatment of patients with EGFR-mutated non–small cell lung cancer.

Gedeptin, a novel gene therapy, is entering phase 2 clinical trials to evaluate its efficacy in treating recurrent head and neck cancer.

While sacituzumab govitecan did not statistically improve overall survival vs docetaxel, there was a numerical improvement observed in patients with non–small cell lung cancer.

The FDA has granted an orphan drug designation to alemtuzumab, a chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia.

IMMN-001 significantly extended overall survival in patients with advanced ovarian cancer when combined with standard chemotherapy, according to phase 2 trial results.

Ayal Aizer, MD, MHS, discussed the changing treatment paradigms of treatment of brain metastases in patients with small cell lung cancer.

The phase 3 IDeate-Lung02 study has dosed its first patient with small cell lung cancer with the investigational antibody-drug conjugate infinatamab deruxtecan.

The Precision Promise and LAPIS studies failed to meet their primary end points of overall survival among patients with pancreatic cancer treated with the investigational agent pamrevlumab.

Dostarlimab plus chemotherapy has been approved for the treatment of all forms of advanced endometrial cancer, including mismatch repair-deficient and microsatellite stable tumors.

VCN-01 has been granted rare pediatric disease designation by the FDA for the treatment of retinoblastoma, a rare eye cancer.

Nicolas Girard, MD, PhD, discussed findings from the PALOMA-2 study investigating subcutaneous vs intravenous amivantamab plus lazertinib for previously untreated, EGFR-mutant non–small cell lung cancer.

Avutometinib plus defactinib shows promising early results in pancreatic cancer, earning an orphan drug designation from the FDA.

The investigational mRNA therapy BNT111 plus cemiplimab showed better overall response rates compared with historical controls in patients with stage III/IV melanoma refractory to anti-PD-(L)1 therapy.

The FDA has granted expanded access to TLX101-CDx, a promising PET imaging agent for diagnosing and monitoring glioma.