News

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.

The FDA’s breakthrough therapy designation for GSK’227 underscores its potential to address the critical unmet needs of patients with relapsed/refractory osteosarcoma.

Abenacianine, a tumor-targeted fluorescent imaging agent, received fast track designation from the FDA after demonstrating its safety and efficacy in visualizing lung tumors in a phase 2 study.

Manmeet Ahluwalia, MD, MBA, FASCO, discusses the prevalence of brain metastases in patients with primary renal cell carcinoma.

The FDA granted priority review to sunvozertinib for the treatment of advanced NSCLC with EGFR exon 20 mutations, based on promising efficacy and safety data from the WU-KONG1 trial.

The MARIPOSA study showed that the combination of amivantamab and lazertinib significantly improved overall survival over osimertinib in EGFR-mutated NSCLC.

Mark A. Lewis, MD, discussed the promise of the ESOPEC and TRANSMET trials and the need for their further investigation.

Amandeep Salhotra, MD, discussed the background and findings from a pilot trial evaluating enasidenib as post-hematopoietic stem cell transplant maintenance therapy for IDH2-mutated acute myeloid leukemia treatment.

The SURPASS-ET trial demonstrated ropeginterferon alfa-2b's superior efficacy over anagrelide, achieving higher durable response rates and greater reduction in JAK2 allele burden among patients with essential thrombocythemia.

Akriti Jain, MD, discusses her presentation from the 2024 American Society of Hematology Meeting and Exposition.

The phase 1 INSIGHT-003 trial of efti, pembrolizumab, and chemotherapy for first-line advanced nonsquamous NSCLC has completed enrollment.

Significant advancements in lung cancer treatment were seen throughout 2024, from new drug approvals to promising clinical trial results.

The FDA approved subcutaneous nivolumab for solid tumors, tiselizumab for advanced gastric and GEJ cancers, and key 2024 breast cancer breakthroughs are reviewed. Experts provide perspective on treatment choices for gastric adenocarcinoma and ctDNA monitoring and clearing in HER2-positive breast cancer.

Pancreatic ductal adenocarcinoma remains a challenge to treat due to its complex biology and resistance mechanisms.

Ghassan K. Abou-Alfa, MD, discusses the findings and key takeaways from the SUMMIT trial, which evaluated the use of neratinib for the treatment of patients with fibrolamellar carcinoma.

Knowing whether repurposing old drugs helps patients with cancer is important, but it will take a concerted investment by public entities such as the National Institutes of Health to make this happen.

Josep Maria Ribera, MD, PhD, discusses the current standard treatment protocols for Philadelphia chromosome-positive acute lymphoblastic leukemia and the rationale behind them.

Ghassan K. Abou-Alfa, MD, discusses neratinib and its use as a monotherapy and in combination with immune checkpoint inhibitors and/or mTOR inhibitors in the SUMMIT trial.

Potential practice-changing therapies in gynecologic cancer include the emergence of carboplatin, paclitaxel, and PD-1 blockade, or the use of fam-trastuzumab deruxtecan-nxki in endometrial cancer.

A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma treatment was submitted to the FDA.

Here is a look back on all the FDA happenings from the month of December 2024.

Recent regulatory activities suggest that the understanding of TROP2-directed therapies remains muddled.

The FDA accepted and granted priority review to an NDA for avutometinib plus defactinib in recurrent KRAS-mutated low-grade serous ovarian cancer.

The FDA indicated paxalisib's overall survival data could support standard approval in glioblastoma, as supported by GBM-AGILE study findings.

Eunice S. Wang, MD, discusses a retrospective study of 105 patients diagnosed with secondary acute myeloid leukemia.

A biologics license application for TLX250-CDx has been submitted to the FDA, as supported by the phase 3 ZIRCON trial showing high accuracy for ccRCC detection.

The past 12 months have seen the FDA approvals of enfortumab vedotin plus pembrolizumab for patients with locally advanced or metastatic urothelial cancer and nivolumab plus cisplatin and gemcitabine for patients with unresectable or metastatic urothelial carcinoma.

2024 saw the establishment of docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil as the preferred regimen for patients with localized adenocarcinoma.

A phase 1 trial evaluating FSHR-targeting CAR T cells for patients with ovarian cancer has dosed the first patient in its third cohort.

Aman Chauhan, MD, highlights an ongoing phase 2 trial exploring the combination of triapine, a radiation sensitizer, with lutetium 177 dotatate for treating well-differentiated somatostatin receptor–-positive neuroendocrine tumors.