Jordyn Sava

A self-taught AI tool that accurately diagnoses adenocarcinoma and predicts cancer recurrence has been developed and has shown to outperform traditional methods.

SL-172154 is being studied in a phase 1a/1b study in acute myeloid leukemia and higher-risk myelodysplastic syndrome, as well as other phase 1 studies in platinum-resistant ovarian cancer.

An investigational new drug application for lomonitinib has been cleared by the FDA for FLT3-mutated relapsed/refractory AML treatment, and a phase 1 trial evaluating the agent will begin in the US.

In the final part of our 3-part series, a roster of developing antibody-drug conjugates gives clinicians and patients hope in hard-to-treat cancers.

The FDA approved imetelstat for treating patients with lower-risk myelodysplastic syndromes with transfusion-dependent anemia, regardless of ring sideroblast status.

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

The FDA granted fast track status to lunresertib and camonsertib for platinum-resistant ovarian cancer with specific mutations, currently being evaluated for safety and efficacy in the phase 1 MYTHIC trial, with results expected in late 2024.

Topline findings from the phase 2 PICCOLO trial support the potential use of mirvetuximab soravtansine for the treatment of folate receptor alpha-positive, platinum-sensitive ovarian cancer.

Pending FDA review, TLX250-CDx awaits consideration following the successful outcomes of the phase 3 ZIRCON trial in clear cell renal cell carcinoma.

An international, multicenter, first-in-human, phase 1/2 study of PFL-002/VERT-002 plans to enroll patients with NSCLC with MET alterations and expects to begin patient enrollment by the end of 2024.

The FDA has cleared a phase 2/3 trial testing KPG-121, a novel drug, combined with abiraterone for first-line treatment of metastatic castration-resistant prostate cancer.

The METIS trial of tumor treating fields for the treatment of brain metastases in patients with non–small cell lung cancer met its primary end point, showing a statistically significant improvement in time to intracranial progression.

A new radioligand therapy, JNJ-6420, shows promise in treating metastatic castration-resistant prostate cancer with deep and lasting responses after just 1-2 doses.

The FDA granted a regenerative medicine advanced therapy designation to TSC-100 and TSC-101 for hematologic malignancies based on encouraging ALLOHA trial data, offering expedited development and review.

Zolbetuximab could become the first CLDN18.2-targeted therapy approved for this patient population in the US.

The FDA has granted a fast track designation to AGuIX, a gadolinium-based nanodrug currently under evaluation for treating malignant gliomas and glioblastoma.

The combination of camrelizumab and rivoceranib significantly improved survival rates in patients with unresectable liver cancer compared with standard treatment.

In an interview with Targeted Oncology, Paolo Ghia, MD, PhD, discussed the 5-year results from the CAPTIVATE study in chronic lymphocytic leukemia and/or small lymphocytic lymphoma.

The FDA has approved a phase 1, first-in-human trial to evaluate the safety and potential effectiveness of ACTM-838, a novel immunotherapy drug for advanced solid tumors.

A Prescription Drug User Fee Act target action date of September 25, 2024, has been set for the application of pembrolizumab plus chemotherapy in advanced mesothelioma.

In an interview with Targeted Oncology, Aleksander L. Chojecki, MD, discussed findings from his research on hematocrit control and thrombotic risk in patients with polycythemia vera treated with ruxolitinib.

AFM24 combined with atezolizumab has received a fast track designation from the FDA for treating advanced/metastatic non-small cell lung cancer without activating EGFR mutations.

A rolling new drug application is being submitted to the FDA for an ovarian cancer treatment combination of avutometinib and defactinib.

Zanidatamab could become the first FDA-approved, HER2-targeted treatment for HER2-positive biliary tract cancer.

As part of its Speaking Out video series, Howard D. Edington, MD, explores how oncolytic viruses are revolutionizing personalized cancer therapy, the challenges of interpreting vast genetic data, and the exciting potential of these targeted therapies.

An FDA advisory committee recommends approval for a new blood test for colorectal cancer screening, potentially offering a more convenient option that could boost screening rates.

In part 2 of our 3-part series, antibody-drug conjugates like enfortumab vedotin and tisotumab vedotin offer novel options for difficult-to-treat tumors.

In an interview with Targeted Oncology, Daniel Nguyen, MD, PhD, further discussed the findings from this phase 2 trial and the potential of vibecotamab.

Pembrolizumab combined with chemotherapy significantly improved overall survival in patients with high-risk early triple-negative breast cancer, according to the prespecified interim analysis of the phase 3 KEYNOTE-522 trial.

In part 1 of our 3-part series, antibody-drug conjugates are revolutionizing oncology, targeting cancer cells precisely. Agents like T-DM1, T-DXd, and sacituzumab govitecan continue to change the field.